MAUDE Adverse Event Report: BECTON DICKINSON & CO. 3 ML SYRINGE; SYRINGE, PISTON

Lot Number 0155075

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Syringe has cracks in it.Fda safety report id # (b)(4).

• Brand Name: 3 ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 10770400
• MDR Text Key: 214395802
• Report Number: MW5097597
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0155075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1