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

Catalog Number 383559

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 06/21/2022

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 tubing burst and caused leakage while using bd nexiva¿ closed iv catheter system.No patient impact reported.The following information was provided by the initial reporter: clinician claims that the tubing burst during a cta injection.

Event Description

It was reported that tubing burst and caused leakage while using bd nexiva¿ closed iv catheter system.No patient impact reported.The following information was provided by the initial reporter: clinician claims that the tubing bursted during a cta injection.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 20-jul-2022 h6: investigation summary bd received an unsealed 18 gauge nexiva single port unit from lot 2024700 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed media in the device and a large tear in the tubing.There was also signs of the tubing ballooning indicating that it had been exposed to high pressures.Next, the device was inspected under a microscope to check for any excess adhesive that may have contributed to the observed damage but no excess adhesive was found.Therefore, based off the engineer's inspection the reported defect was verified.However, since the device appeared to have been used and returned in an unsealed package a definitive root cause could not be determined.The observed damage could have occurred during the manufacturing process or during use due to the signs of high pressure exposure.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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 ; 8015296192
• MDR Report Key: 15080574
• MDR Text Key: 304509657
• Report Number: 1710034-2022-00377
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835591
• UDI-Public: 00382903835591
• 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,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383559
• Device Lot Number: 2024700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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