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 Problems Leak/Splash (1354); Material Rupture (1546); Deformation Due to Compressive Stress (2889)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector tubing ballooned and burst, spraying saline all over the room.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "nexiva co packaged with max zero.Tubing is ballooning/blowing.This has happened 3 times in ct and they are not clamped! one time 2.0 push contrast omnipaque 350.One time 4.5 mil/sec, and one time with hand flush.One time it blew and saline went all over the room.".

Manufacturer Narrative

H6: investigation summary a physical sample was not available for investigation but bd was provided with a photo 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 photo and observed that the extension tubing had expanded and deformed near the catheter adapter but it could not be determined if the tubing ruptured or not.If the tubing had ruptured it was likely that this caused the reported leakage but without evidence in the provided photo the engineer could not make this determination.There was also no signs of leakage in the provided photo.Therefore, based off the provided photo the engineer was able to verify the reported defect of ballooned tubing but could not verify the reported issue of leakage or ruptured tubing.Unfortunately, without a physical sample available to inspection a definitive root cause could not be determined.H3 other text : see h10.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector tubing ballooned and burst, spraying saline all over the room.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "nexiva co packaged with max zero.Tubing is ballooning/blowing.This has happened 3 times in ct and they are not clamped! one time 2.0 push contrast omnipaque 350.One time 4.5 mil/sec, and one time with hand flush.One time it blew and saline went all over the room.".

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16994182
• MDR Text Key: 315861390
• Report Number: 1710034-2023-00563
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/14/2023
• 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