MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383512

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/04/2019

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¿ closed iv catheter systems were found mixed in with the dual port catheter stock and found before use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "a nurse had identified multiple single port bd nexiva catheters mixed in with the dual port unit stock.The packaging of all items in this complaint did not contain a q-syte (missing part).There was 1 dual port 22g bd nexiva catheter identified to also be missing a q-syte.This is the only package that was opened by the nurse.All others (the single port catheters) have closed packaging.".

Event Description

It was reported that bd nexiva¿ closed iv catheter systems were found mixed in with the dual port catheter stock and found before use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "a nurse had identified multiple single port bd nexiva catheters mixed in with the dual port unit stock.The packaging of all items in this complaint did not contain a q-syte (missing part).There was 1 dual port 22g bd nexiva catheter identified to also be missing a q-syte.This is the only package that was opened by the nurse.All others (the single port catheters) have closed packaging.".

Manufacturer Narrative

Investigation summary: observations and testing could not be performed in the absence of a sample.A review of the device history record revealed no irregularities during the manufacture of the reported lot.The defect adapter / connector missing -mixed product / lots could not be refuted nor confirmed in the absence of a sample.Conclusion(s): not determined: the root cause cannot be determined for an unconfirmed defect.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9355171
• MDR Text Key: 177392732
• Report Number: 1710034-2019-01235
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: 30382903835127
• 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: 12/26/2019

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 383512
• Device Lot Number: 9137627
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other