MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 383556

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 4 of the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector tubing ruptured.2 of 2 reported events.The following information was provided by the initial reporter: xxx indicated that item had issue with bursting on the hose part of the item.What is the patient outcome? are there any adverse events/serious injuries? pt had to have the affected iv removed and a replacement iv started.Was there a delay of, or change in, the course of treatment due to the event? delay of ct imaging due to the need to remove and restart iv access.What type of procedure is being performed? ct imaging.What was the medication/fluid in use at the time of the event? ct contrast.Was there any leakage of medication/fluid? no.The technician saw the tubing expanding and terminated the infusion before the j-loop tubing burst open.

Manufacturer Narrative

H6: investigation summary a physical sample was not available for investigation but bd was provided with two photos of the issue for evaluation.A review of the device history record was performed for the reported lot, 3038466, and no quality issues were found during production.Our quality engineer reviewed the provided photos and observed that the device appeared to be used with the extension tubing having expanded and became deformed near the catheter adapter.Therefore, based off the provided photos the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for inspection a definitive root cause could not be determined as the observed damage could have been caused by a few different events.

Event Description

It was reported that 4 of the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector tubing ruptured.2 of 2 reported events.The following information was provided by the initial reporter: xxx indicated that item had issue with bursting on the hose part of the item.What is the patient outcome? are there any adverse events/serious injuries? pt had to have the affected iv removed and a replacement iv started.Was there a delay of, or change in, the course of treatment due to the event? delay of ct imaging due to the need to remove and restart iv access.What type of procedure is being performed? ct imaging what was the medication/fluid in use at the time of the event? ct contrast was there any leakage of medication/fluid? no.The technician saw the tubing expanding and terminated the infusion before the j-loop tubing burst open.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16989233
• MDR Text Key: 315826794
• Report Number: 1710034-2023-00549
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903835560
• UDI-Public: 00382903835560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383556
• Device Lot Number: 3038466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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