MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD LUER-LOK; SYRINGE, PISTON

Model Number 309653

Device Problems Contamination (1120); Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

The pharmacy department has identified a small amount of 50ml bd syringes (lot 1335318) with particulate inside of the syringe barrel.The particulate appears to be plastic shavings.The pharmacy department sequestered all of the 50ml bd syringes.The pharmacy department reported this to the manufacturer.Manufacturer response for syringe, piston, bd luer-lok (per site reporter).No response yet.

• Brand Name: BD LUER-LOK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 13807856
• MDR Text Key: 287403397
• Report Number: 13807856
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: (01)30382903096535
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 309653
• Device Catalogue Number: 309653
• Device Lot Number: 1335318
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1