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

Catalog Number 305832

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/01/2021

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 vaccine medicine leaked from the bottom of the bd flu+¿ syringe.The following information was provided by the initial reporter: "vaccine noted to be leaking out of the bottom of the syringe, no injury, syringe filled with vaccine disposed of.".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided lot number 2012414.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.As samples were unavailable for this incident, twenty retained samples of the same lot number were obtained from the manufacturing facility for further evaluation.The retained samples were examined and no signs of leakage were identified.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.

Event Description

It was reported that vaccine medicine leaked from the bottom of the bd flu+¿ syringe.The following information was provided by the initial reporter: "vaccine noted to be leaking out of the bottom of the syringe, no injury, syringe filled with vaccine disposed of.".

• Brand Name: BD FLU+ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 12147421
• MDR Text Key: 261752645
• Report Number: 3002682307-2021-00314
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K091377
• 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: 08/23/2021

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: 305832
• Device Lot Number: 2012414
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1