MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP

Catalog Number 307727

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that bd emerald¿ 2ml syringe, luer slip centric tip snapped off during use.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Upon visual inspection of the returned sample we were able to verify the reported issue of a broken tip.While the specific lot of the defective product was unknown, we completed a batch history review for all lots that were reported to be in use at your facility.Our review did not identify any non-conformances associated with this issue during the production of these batches.Bd performs thorough inspections in order to reduce any type of defects with our product.We have two detection systems that have been implemented to aid in our inspections, the first being in the assembly machine.In this station the syringe is allocated vertically, tip is clogged, and the plunger is pushed.If there is no loss of air in the syringe, that means that is no leak and the syringe is good.If the tip of the syringe is broken in that station, the machine would reject it automatically.Next within the primary packaging machine, inside the syringe feeder the syringes are allocated with a sensor that detects the absence of a tip and stops automatically if detected.Given the available information, we think that the syringe tip could break as a consequence of any imperceptible damage in the barrel.If there was a minor defect that was not detectable in our inspection process, the tip could break as a result of both the minor defect along with the force used to engage the product.We can ensure that the probability of finding this kind of defect is very low and any recurrence is unlikely in our products since review syringe dhr showed no indication of the alleged defect, considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no actions are required.

Event Description

It was reported that bd emerald 2ml syringe, luer slip centric tip snapped off during use.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: yes.

Event Description

"it was reported that bd emerald 2ml syringe, luer slip centric tip snapped off during use.There was no report of exposure, injury or medical intervention.".

• Brand Name: BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7723377
• MDR Text Key: 115293776
• Report Number: 3002682307-2018-00179
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 307727
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other