MAUDE Adverse Event Report: BD BD 50 ML LUER LOK SYRINGE; SYRINGE, PISTON

Model Number REF 309653

Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Removed bd 50 ml syringe (ref 309653, lot 1307874 exp 10/31/2026) from overwrap for compounding.Syringe flanges noted to be discolored brown, distinctly different from rest of barrel.Additionally many black spots all over the syringe (appear to be embedded in plastic, cannot wipe them off).Reviewed remaining syringe of the same lot, no other syringes appear to be affected.Fda safety report id# (b)(4).

• Brand Name: BD 50 ML LUER LOK SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 13342312
• MDR Text Key: 284450323
• Report Number: MW5106917
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 309653
• Device Lot Number: 1307874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1