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

Model Number 309646

Device Problem Contamination (1120)

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

Event Date 01/18/2019

Event Type  malfunction  

Event Description

12 syringes in a lot of bd 5cc leur lock syringes were found to what appears to be come sort of contamination inside the sterile wrap packaging.Manufacturer response for leur lock syringe, (brand not provided) (per site reporter).None to date.

• Brand Name: BD LUER-LOK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton dr; franklin lakes NJ 07417
• MDR Report Key: 8296532
• MDR Text Key: 134784970
• Report Number: 8296532
• Device Sequence Number: 1
• Product Code: FMF
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 309646
• Device Catalogue Number: 309646
• Device Lot Number: 8267575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1