MAUDE Adverse Event Report: BECTON DICKINSON BD LUER-LOK; LUER-LOK SYRINGE

Catalog Number 309646

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

When removed from sterile package, it was noted that plunger was defective and deformed.

• Brand Name: BD LUER-LOK
• Type of Device: LUER-LOK SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 4079927
• MDR Text Key: 20298232
• Report Number: 4079927
• Device Sequence Number: 1
• Product Code: JKA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/28/2014

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: Invalid Data
• Device Catalogue Number: 309646
• Device Lot Number: 4090094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1