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

Catalog Number 383551

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 05/07/2018

Event Type  Death  

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 a nurse placed the bd nexiva¿ closed iv catheter system instead of a sq butterfly.Despite them being well labelled.The patient was palliative and died due to disease progression.Nurse stated they looked the same and she thought the nexiva was the sq butterfly.Found during use.

Manufacturer Narrative

No sample or photo was returned for evaluation.A review of the device history records revealed no irregularities during the manufacture of reported lot number 7143594.Without defective sample or photo for us is very difficult to determine the root of cause of the incident.We were not able to associate the reported defect to the mfg.Process.No capa was opened since this issue could not be confirmed as manufacturing related.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7531192
• MDR Text Key: 108844951
• Report Number: 9610847-2018-00148
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835515
• UDI-Public: 00382903835515
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 383551
• Device Lot Number: 7143594
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2017
• 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): Death