MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383516

Device Problem Infusion or Flow Problem (2964)

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

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd nexiva¿ closed iv catheter system extension tubing blew up during use.The following information was provided by the initial reporter: material no.: 383516, batch no.: unknown.It was reported that the extension tubing blew up at both ends while in use.20g catheter tubing blew up going 2.5ml/sec and the injector was told to have been set at 300psi.Radiology has had an issue with a 20g nexiva iv cath.Both ends of the tubing ¿blew up¿.This product appears to be a nexiva catheter and not a nexiva diffusics.

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with photos of the defect for evaluation.A review of the device history record could not be performed as the lot number was unknown.Our quality engineer reviewed the provided photos and determined that the tubing was ballooning directly above the nose of the luer adapter and directly below the clear port of the winged adapter.Based off the provided photos the engineer was able to verify the reported defect.However, without the physical sample available for testing a definitive root cause could not be determined.Ballooning of the tubing is generally caused by occlusion or incorrect pressure in the line.

Event Description

It was reported that bd nexiva¿ closed iv catheter system extension tubing blew up during use.The following information was provided by the initial reporter: material no.: 383516 batch no.: unknown.It was reported that the extension tubing blew up at both ends while in use.20g catheter tubing blew up going 2.5ml/sec and the injector was told to have been set at 300psi.Radiology has had an issue with a 20g nexiva iv cath.Both ends of the tubing ¿blew up¿.This product appears to be a nexiva catheter and not a nexiva diffusics.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8740660
• MDR Text Key: 149555977
• Report Number: 1710034-2019-00684
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: 30382903835165
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383516
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other