MAUDE Adverse Event Report: BRAUN / B. BRAUN MEDICAL INC. NITINOL MANDREL WIRE W/ PLATINUM; WIRE, GUIDE, CATHETER

Model Number 01840NP

Device Problems Break (1069); Material Frayed (1262); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2020

Event Type  Injury  

Event Description

Guidewire broke off upon placement in ij.Upon attempt to insert wire was not advancing pulled back and end of wire was frayed and tip missing.Retained in patient.Fda safety report id # (b)(4).

• Brand Name: NITINOL MANDREL WIRE W/ PLATINUM
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BRAUN / B. BRAUN MEDICAL INC.
• MDR Report Key: 11036598
• MDR Text Key: 222649232
• Report Number: MW5098434
• Device Sequence Number: 1
• Product Code: DQX
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 01840NP
• Device Catalogue Number: 310410
• Device Lot Number: P20133069
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO
• Patient Weight: 5