MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE

Catalog Number 309702

Device Problems Filling Problem (1233); Improper Flow or Infusion (2954)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the rubber plunger in a bd luer-lok¿ syringe appeared to be "unleveled when filled with product and suspected of not getting an accurate fill volume." there was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

No samples were received for this complaint.Product defect not confirmed based on photos provided.No root cause identified since defect was not confirmed based on photos provided.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the rubber plunger in a bd luer-lok syringe appeared to be "unleveled when filled with product and suspected of not getting an accurate fill volume." there was no report of exposure, injury, or medical intervention.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7647836
• MDR Text Key: 112854950
• Report Number: 1213809-2018-00418
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903097020
• UDI-Public: 30382903097020
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 309702
• Device Lot Number: 8057668
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other