MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD NEXIVA IV START KIT; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 383519

Device Problems Break (1069); Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

Event Type  Injury  

Event Description

Anesthesia inserting peripheral iv catheter and tubing broke off from the cannula leaving needle and cannula separated.Catheter was removed and no harm to pt.

• Brand Name: BD NEXIVA IV START KIT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. ; sandy UT 84070
• MDR Report Key: 7600627
• MDR Text Key: 111198452
• Report Number: MW5077852
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835195
• UDI-Public: (01)00382903835195
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2018

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 Expiration Date: 11/30/2020
• Device Model Number: 383519
• Device Lot Number: 7339690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2018
• 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