MAUDE Adverse Event Report: BD BD PLASTIPAK 3ML SYRINGE; SYRINGE, PISTON

Catalog Number 309657

Device Problems Material Discolored (1170); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Event Description

Rn went to get a syringe to draw up medication.Upon opening the packaging she noticed brown marks all over the syringe.

• Brand Name: BD PLASTIPAK 3ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 16683570
• MDR Text Key: 312802426
• Report Number: MW5116320
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309657
• Device Lot Number: 1260169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1