MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ NEXIVA; PERIPHERAL VASCULAR CATHETER

Catalog Number 383536

Device Problem Burst Container or Vessel (1074)

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

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd¿ nexiva was blown up during use.

Manufacturer Narrative

Correction: in the previously submitted mdr, brand name and type of reportable event were incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: medical device expiration date.Device manufacture date.

Event Description

It was reported that bd¿ nexiva was blown up during use.

Manufacturer Narrative

H.6.Investigation summary: dhr- the lot number was unknown therefore review could not be performed.Received a 20ga nexiva catheter-adapter extension set along with a specimen bottle.The needle-grip assembly and packaging were not returned for evaluation.Visual/microscopic evaluation: the pinch clamp was not engaged.Traces of patient residue and medicine was observed on the catheter adapter and on the extension set.The tubing was ballooned entirely from the y adapter and up the port on the wing adapter.¿a portion of the tubing had been blown up (burst).Conclusion(s): a definite source that caused the tubing to balloon could not be determined, the extension tubing may be damaged and/or ballooned if the catheter becomes occluded, occlusion of the unit will increase the internal pressure and can cause the tubing to break, balloon and /or burst.Potential contributors to failure (for used extension tube): 1- had a kinked /or occluded catheter tubing during usage, this could increase the pressure within the extension tubing and cause it to balloon, split and/or burst.2- infusion not performed correctly or at a psi or flow rate above the recommendations per nexiva instructions for use.

Event Description

It was reported that bd¿ nexiva was blown up during use.

• Brand Name: BD¿ NEXIVA
• Type of Device: PERIPHERAL VASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8204500
• MDR Text Key: 131764013
• Report Number: 1710034-2018-00959
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383536
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/13/2018; 12/13/2018
• Supplement Dates FDA Received: 01/28/2019; 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other