FIELD SAFETY NOTICE – MPS-18-1209

BD Syringes and Needles

REF: Refer to Table 1
Type of Action: Advisory

Attention: Clinical Engineering Managers, Clinical Personnel, Risk Managers
This letter contains important information which requires your attention.

Dear Customer,

BD is issuing this Field Safety Notice for the BD Syringes and Needles listed in Table 1 below to advise of an added caution.

 

Table 1: List of impacted products

309628 – BD 1ml Syringe Luer-Lok™ Tip
303172 – BD Plastipak™ 1ml Luer
305211 – BD Blunt Fill Needle with Filter 18G x 1 1/2 (1.2mm x 40mm) (5μm)
302809 – BD Microlance™ 3 30G x ½” 0,3 x 13mm
304000 – BD Microlance™ 3 30G x ½” 0,3 x 13mm

 

Description of the Problem

It has been identified through post-market surveillance reviews that a caution should be added to the Instructions for Use (IFU) for the products listed in Table 1 above.

Note: The above listed products are not to be used for ocular medications due to the increased potential for adverse eye conditions, as outlined below.

This Field Safety Notice is providing the following caution and BD recommends it be applied when using the product.

Intraocular use is not validated by BD

BD has become aware that when syringes and needles are used for intraocular injections, the potential exists for “floaters” in patients’ eyes which are believed to be due to silicone. (Note: Syringes and needles manufactured by BD have silicone applied to the inside of the barrels to provide lubrication for the plunger stopper, allowing it to move easily). The potential hazard is deposition of silicone oil (SO) droplets in the vitreous. The potential harm could be symptomatic “floaters” in the patient’s field of vision which, normally, are tolerable and resolve over a few months. However, if sufficiently bothersome, floaters may lead to a vitrectomy for their removal.

BD became aware of other potential risks associated with intraocular injections, such as endophthalmitis (inflammation of the interior of the eye), which may be associated with failure modes not previously identified by BD.

To reduce this risk of silicone floaters and inflammation or irritation that may occur, HCPs should only use the syringes and needles provided with ocular medications that are specifically designed and labelled for intravitreal injection.

Following reports of use in intra-ocular procedures BD is updating the IFU and future product being shipped by BD will contain the caution.

Advice on actions to be taken by the user:

  1. Ensure the contents of this Field Safety Notice, including the contraindications, are read and understood by those within your organisation who may use the BD syringes and needles listed in Table 1 above.
  2. If you have further distributed the product to other organisations, please identify those organisations and notify them at once of this Field Action.
  3. Please complete the Customer Response form located at the button below and return the completed form to BD at BDUKFieldAction@bd.com no later than 29th January 2021.
  4. If you are no longer in possession of or no longer use the -devices listed in above, please indicate this on the response form and return to BD so we may update our records.

Should you have any questions or experience any issues associated with the product or issue described in this Field Safety Notice, please contact BDUKFieldAction@bd.com. BD has notified the appropriate regulatory agencies of these actions.

BD is committed to ensuring that safe and effective product is available to customers and this Field Safety Notice is taken with due consideration of this commitment.