MAUDE Adverse Event Report: BD BD 20 ML SYRINGE WITH LUER LOCK TIP (REF 302830); SYRINGE, PISTON

Model Number 302830

Device Problems Material Fragmentation (1261); Product Quality Problem (1506); Component Missing (2306); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The batch of bd 20 ml luer lock syringes that we have in stock appear to have quality control issues.One had a shattered plunger, one had the markings on the cylinder wrapped around the cylinder instead of going down in a straight line, and a third one was missing the black seal on the plunger.Reference reports mw5117757, mw5117758.

• Brand Name: BD 20 ML SYRINGE WITH LUER LOCK TIP (REF 302830)
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 16983653
• MDR Text Key: 315780400
• Report Number: MW5117756
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: 2298739
• 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