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

Catalog Number 383557

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd nexiva closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1.25 in (1.1 x 32 mm) has been found with the needle through the catheter during use.The following has been provided by the initial reporter: it was reported that the wire went through the plastic catheter tip and the iv blew.Per email: when the nurse was attempting to start and iv, when threading the catheter the wire went through the plastic catheter tip and the iv blew.Bd nexiva closed iv catheter system single port with maxzero needleless connector.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8025512.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.A sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It has been reported that one bd nexiva closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1.25 in (1.1 x 32 mm) has been found with the needle through the catheter during use.The following has been provided by the initial reporter: it was reported that the wire went through the plastic catheter tip and the iv blew.Per email: when the nurse was attempting to start and iv, when threading the catheter the wire went through the plactic catheter tip and the iv blew.Bd nexiva closed iv catheter system single port with maxzero needleless connector.

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM¿ SINGLE PORT W MAXZERO¿ NEEDLELESS CONNECTOR
• 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 ; MX
• MDR Report Key: 8847990
• MDR Text Key: 153157092
• Report Number: 9610847-2019-00494
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835578
• UDI-Public: 30382903835578
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 383557
• Device Lot Number: 8025512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other