MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ SYRINGE; PISTON SYRINGE

Catalog Number 301942

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2022

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

It was reported that 500 bd¿ syringes had plunger leakage issues.The following information was provided by the initial reporter, translated from chinese to english: the distributor reported that the syringe leaked when the liquid was drawn after opening the package and the quantity is temporarily uncertain.

Manufacturer Narrative

Investigation summary: a device history record review was completed for provided material number 301942 and lot number 2107191.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, a video sample was returned for evaluation by our quality engineer team.Through examination of the video, the reported defect could be confirmed.Based on the provided feedback and the video sample, we have concluded that this type of damage may result as a consequence of damage to the plunger lip component.This type of damage can be produced during the handling of the product through the manufacturing process or within the plunger assembly machine.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.

Event Description

It was reported that 500 bd¿ syringes had plunger leakage issues.The following information was provided by the initial reporter, translated from chinese to english: the distributor reported that the syringe leaked when the liquid was drawn after opening the package and the quantity is temporarily uncertain.

• Brand Name: BD¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15160920
• MDR Text Key: 297249645
• Report Number: 3002682307-2022-00203
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301942
• Device Lot Number: 2107191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1