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

Model Number 20 GAUGE X 1.25

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/13/2018

Event Type  malfunction  

Event Description

Blue connector on 20 gauge x 1.25 iv nexiva catheter failed during induction of patient requiring the connector to be removed and the iv line reconnected.Third incident of this type of equipment failure as noted by anesthesia.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by sending an e-mail to the address below.

• Brand Name: IV NEXIVA CATHETER
• 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 1880
• MDR Report Key: 7406283
• MDR Text Key: 104877322
• Report Number: MW5076371
• Device Sequence Number: 2
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 03/31/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20 GAUGE X 1.25
• 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
• Patient Age: 74 YR