MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ CONVENTIONAL SYRINGE

Catalog Number 301027

Device Problem Defective Device (2588)

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

Event Date 11/15/2018

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 plunger stopper bd¿ conventional syringe were defective before use.

Manufacturer Narrative

Investigation: four loose 5ml assembled syringes were received and visually evaluated.Two syringes were observed to have jammed stopper condition and two syringes were observed to have bent flanges.Both conditions are rejectable per product specification.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Potential root cause for the jammed stopper and bent flange defects is associated with the assembly process.

Event Description

It was reported that plunger stopper bd¿ conventional syringe were defective before use.

• Brand Name: BD¿ CONVENTIONAL SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8197212
• MDR Text Key: 131480542
• Report Number: 1213809-2018-00925
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 301027
• Device Lot Number: 8234740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other