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

Catalog Number 383517

Device Problem Defective Device (2588)

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

Event Date 11/21/2023

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.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.

Event Description

It was reported that a crack in the bd nexiva¿ closed iv catheter system's yellow rubber stopper was rounded.It was reported by consumer that yellow rubber stopper above gray stopper was defective and rounded.Allowed air through catheter and caused lab specimen to have air bubbles in it.Iv was switched out.Additional information provided 12/26/2023: slight delay to switch out supply, during patient use, no injury.

Manufacturer Narrative

Investigation results: two photographs were provided for investigation.One photo showed two 20g nexiva iv catheters that were shown side by side.Both samples exhibited evidence of use.The septum was circled on each device.One septum exhibited no defect or damage.The mold cavity number on the catheter adapter was n1 d14.A portion of the other septum appeared to be caught between the cannister and catheter adapter.The mold cavity number on the catheter adapter was a14.The second photo showed a single 20g nexiva device, which resembled the sample from mold cavity #a14.A portion of the septum appeared to be caught between the cannister and catheter adapter.The observed damage would likely allow fluid to bypass the septum.The customer reported that air was able to enter the catheter.Damage to the septum and/or canister may occur during assembly due to misalignment or damaged tooling/grippers.During manufacturing, operators perform leak testing and inspections for damaged components per the sampling and quality control plan to mitigate the occurrence of this defect.Investigation conclusion(s): the defect of "catheter defective/damaged" was confirmed probable root cause: manufacturing.A notification of awareness has been sent to the manufacturing department.

• 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18442562
• MDR Text Key: 331865518
• Report Number: 1710034-2023-01499
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: (01)30382903835172
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383517
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1