BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SP WITH MAXZERO

    MDR report key: 20540992 · Received October 27, 2024

    Report

    Report Number
    1710034-2024-01207
    Event Type
    Malfunction
    Date Received
    October 27, 2024
    Date of Event
    October 4, 2024
    Report Date
    November 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835577
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IT IS UNCLEAR IF THE DISTRIBUTOR IS REPORTING 3 OCT THIS AS THE EVENT DATE OR THEIR AWARE DATE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383557 AND LOT NUMBER 4152107. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO NEEDLE DISENGAGEMENT DIFFICULTY RESULTING IN PIERCED CATHETER AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DESCRIPTION: DIFFICULT TO RETRACT. REPORTED ISSUE: THE NEEDLE IS SUPER DIFFICULT TO RETRACT AND WILL ACTUALLY GRIND WHILE FORCING A RETRACTION. IN SOME INSTANCES, THE FORCE THAT HAS HAD TO BE USED TO RETRACT THE NEEDLE HAS CAUSED A PUNCTURE IN THE TUBING WHICH THEN LEAKS AND WE HAVE TO RE-STICK THE PATIENT. INJURIES OR ADVERSE EVENT: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819268 BD NEXIVA SP WITH MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152107 00382903835577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown