MAUDE Adverse Event Report: BD 1 ML SYRINGE; SYRINGE, PISTON

Model Number 309628

Device Problems Contamination /Decontamination Problem (2895); Packaging Problem (3007)

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

Event Date 02/10/2020

Event Type  malfunction  

Event Description

Syringe appears to have cardboard particles inside the sterile packaging.

• Brand Name: 1 ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 9793182
• MDR Text Key: 182546112
• Report Number: MW5093532
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 9170668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1