MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 383516

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 02/04/2022

Event Type  malfunction  

Event Description

Piv catheter shredded inside of patients vein while placing it.Piv placed from emergency medical services (ems) also kinked multiple times.

• Brand Name: BD NEXIVA
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 13558803
• MDR Text Key: 285819025
• Report Number: 13558803
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: (01)30382903835165
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383516
• Device Catalogue Number: 383516
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Male