BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL

    MDR report key: 19169752 · Received April 23, 2024

    Report

    Report Number
    1710034-2024-00348
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810444
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381044 AND LOT NUMBER 4012529 . 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. 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.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION FROM THE CUSTOMER: THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IAG BC PRO GLOBAL NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INSERTION OF A BD INSYTE AUTOGUARD BC PRO 18G CATHETER, WHEN I PRESSED TO RETRACT THE CATHETER NEEDLE, THE NEEDLE/CATHETER ASSEMBLY STARTED TO COME OUT OF THE VEIN (ALTHOUGH THE CATHETER WAS WELL MOUNTED AND POSITIONED). I BLOCKED THE WHOLE THING WITH A FINGERNAIL AND REALIZED THAT IT WAS THE GREEN PLASTIC EDGE THAT HAD BEEN BLOWN OFF AND WAS BLOCKING THE RETRACTION SYSTEM. I WAS ABLE TO CLEAR THE PLASTIC FLANGE AND DIDN'T NEED TO REINSTALL A CATHETER, BUT THE ANTI-REFLUX SYSTEM WASN'T WORKING AND I WAS SURPRISED TO SEE BLOOD FLOWING BACK INTO THE NEEDLE RETRACTION POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382871 BD IAG BC PRO GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4012529 00382903810444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown