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

Model Number 383557

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: unknown.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 during use the needle went through the catheter with a bd nexiva closed iv catheter system ¿ single port with maxzero¿.The following information was provided by the initial reporter: (1 of 2 complaints).It was reported that when catheter inserted and the needle poked through the catheter causing the patient to bleed.

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿
• Type of Device: INTRAVASCULAR CATHETE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9643293
• MDR Text Key: 194706915
• Report Number: 9610847-2020-00025
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835578
• UDI-Public: 30382903835578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2020

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 Expiration Date: 08/31/2022
• Device Model Number: 383557
• Device Catalogue Number: 383557
• Device Lot Number: 9235882
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other