MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383591

Device Problem Structural Problem (2506)

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

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that before use of the bd nexiva¿ closed iv catheter system the "catheter was removed from the packaging to find catheter tip extended past end of needle shaft.".

Event Description

It was reported that before use of the bd nexiva¿ closed iv catheter system the "catheter was removed from the packaging to find catheter tip extended past end of needle shaft.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 6153743.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8323729
• MDR Text Key: 136140505
• Report Number: 9610847-2019-00135
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835912
• UDI-Public: 30382903835912
• Combination Product (y/n): N
• PMA/PMN Number: K173354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 383591
• Device Lot Number: 6153743
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other