BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO

    MDR report key: 19028303 · Received April 2, 2024

    Report

    Report Number
    1710034-2024-00275
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 13, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903925230
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    501

    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.

    Additional Manufacturer Narrative · 0

    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 392523 AND LOT NUMBER 3222379. 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. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IAG BC PRO NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WOULD NOT SAFETY CUSTOMER RESPONSE ON MARCH 15, 2024. 1. RN INSERTED THE DEVICE AND UPON SEEING BLOOD RETURN, ADVANCED SLIGHTLY AND PUSHED WHITE BUTTON TO RETRACT NEEDLE. DESPITE A FEW ATTEMPTS, NEEDLE DID NOT RETRACT. RN TRIED TO MANUALLY FORWARD CATHETER INTO VEIN AND COULD NOT. REMOVED DEVICE ENTIRELY AND CALLED MANAGER (MYSELF) TO LOOK. 2. NO INJURY, BUT NEEDLE EXPOSED AND PATIENT HAD TO HAVE NEW IV STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405710 BD IAG BC PRO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3222379 00382903925230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown