MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL CLEAR 14GA 1-1/4IN

Catalog Number 309742

Device Problems Leak/Splash (1354); Inappropriate Audible Prompt/Feedback (2280)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 50ml ll clear 14ga 1-1/4in leaked and syringe pump alarms.This occurred on 3 occasions.The following information was provided by the initial reporter: during the use, the drawn liquid flows to the back through the stopper.Procurement has samples available.We notice that rests remain in the perfursor syringes when placing them in the space-perfusoren and selecting the right software.

Manufacturer Narrative

H6: investigation summary: seven used samples were provided to our quality team for investigation.Through visual inspection, a leakage past the stopper ribs was observed in all received samples.The product was disassembled for further inspection, in six of the samples it was confirmed there was no damage in the plunger rod or other components that could have caused a leak.One syringe was observed to have damage on the barrel, a dent was noted near the 50ml marking.A device history review was performed for the reported lot 1912211, an incident was detected related to the imbalance of the ball bearings in the assembly station which resulted in barrels jamming within the machine.Once identified, our mechanical team repaired this issue and defective units were scrapped.It is likely this impacted unit was not properly detected.There was no non-conformances identified during manufacturing that could have contributed to the reported defect of medication remaining in the syringe.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, including tightness testing to verify the stopper seal and silicone content and force testing to verify proper plunger movement.Five retained samples of lot 1912211 were used to conduct these tests, in all cases the product functioned as intended and was verified to be within required specifications.Based on our investigation and sample evaluation, we cannot identify a defective root cause at this time.In relation to the one damaged syringe, the leak was likely a result of the dent observed on the syringe barrel which occurred during manufacturing.H3 other text : see h10.

Event Description

It was reported that syringe 50ml ll clear 14ga 1-1/4in leaked and syringe pump alarms.This occurred on 3 occasions.The following information was provided by the initial reporter: 1) during the use, the drawn liquid flows to the back through the stopper.Procurement has samples available.2) we notice that rests remain in the perfursor syringes when placing them in the space-perfusoren and selecting the right software.

• Brand Name: SYRINGE 50ML LL CLEAR 14GA 1-1/4IN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11341465
• MDR Text Key: 232334343
• Report Number: 3003152976-2021-00091
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309742
• Device Lot Number: 1912211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1