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

Model Number 383537

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Patient Involvement (2645)

Event Date 09/06/2019

Event Type  malfunction  

Event Description

Emergency room (er) nurse wrote - "we opened up a 20g bd nexiva 1.25 inch iv and the catheter/needle was extremely long, much longer than 1.25 inch.We checked all of the same lot number that we could find and did not find any other." not used, placed back in package and sent to safety officer.Held in my office if bd decides to retrieve for evaluation.Bd notified of this today.

• Brand Name: BD NEXIVA, BD Q-SYTE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 9145480
• MDR Text Key: 160887185
• Report Number: 9145480
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835379
• UDI-Public: (01)00382903835379
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383537
• Device Catalogue Number: 383537
• Device Lot Number: 9155871
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1