BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 19353787 · Received May 20, 2024

    Report

    Report Number
    1710034-2024-00457
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 25, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383536 AND LOT NUMBER 4030906. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE GRAY TIP SHIELD COMPONENT DID NOT WANT TO SEPARATE FROM THE CATHETER ADAPTER COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 20G NEXIVA UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #4030906. A FUNCTIONAL TEST SHOWED THAT THE NEEDLE FULLY RETRACTED WITHOUT COMPLICATION AND THE TIP SHIELD SAFETY MECHANISM FULLY SEPARATED FROM THE CATHETER ADAPTER. THE AFFECTED UNIT WAS NOT PROVIDED FOR INVESTIGATION. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, A CORRECTIVE ACTION INITIATION DETERMINATION (CID) WAS OPENED DUE TO THE NUMBER OF SIMILAR COMPLAINTS FROM THIS LOT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA, NEEDLE DISENGAGEMENT DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRAY PIECE NOT WANTING TO PUSH FORWARD AND SAFETY PIECE NOT WANTING TO PULL BACK. COMMENTS ON (B)(6) 2024. I WOULD LIKE TO CLARIFY THE DESCRIPTION OF THE COMPLAINT. THE GRAY AND WHITE PIECE OF THE CATHETER WORKS AS IT SHOULD. NO TROUBLE ADVANCING THE CATHETER INTO THE VEIN. IT IS WHEN THE CATHETER IS PLACED AND YOU WANT TO REMOVE THE NEEDLE FROM THE HUB THAT THE ISSUE OCCURS. THE GRAY PIECE DOES NOT WANT TO SEPARATE FROM THE CATHETER HUB. IT DID NOT INVOLVE URGENT/LIFE THREATENING MEDICAL SITUATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749820 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030906 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown