MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL

Catalog Number 300865

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Hold for kc 8.21 it was reported that an unspecified number of syringes 50ml ll experienced product damage/deformation -device still operable.Product defect was noted prior to use.The following information was provided by the initial reporter: defect noticed on the syringe, before use.No consequences, dissatisfaction.Device available for expertise.Information received on december 11: when preparing an electric syringe pump, when the piston was moved, the black rubber tip under the piston bent.

Manufacturer Narrative

H.6.Investigation summary : one sample of lot 1909230 was provided to our quality team for investigation.Upon visually inspecting the product, the stopper is observed to be partially disassembled from the plunger.The product was disassembled for further inspection, there was no damage noted in the plunger rod or other components that could have contributed to this defect.A device history was performed and found no no-conformances related to the reported issue during production of batch 1909230.This issue was determined to have occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that an unspecified number of syringes 50ml ll experienced product damage/deformation -device still operable.Product defect was noted prior to use.The following information was provided by the initial reporter: defect noticed on the syringe, before use.No consequences, dissatisfaction.Device available for expertise.Information received on december 11: when preparing an electric syringe pump, when the piston was moved, the black rubber tip under the piston bent.

• Brand Name: SYRINGE 50ML LL
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9527727
• MDR Text Key: 203867734
• Report Number: 3003152976-2019-00886
• 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
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 1909230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other