BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL

    MDR report key: 18461170 · Received January 6, 2024

    Report

    Report Number
    1710034-2023-01509
    Event Type
    Malfunction
    Date Received
    January 6, 2024
    Date of Event
    December 9, 2023
    Report Date
    February 23, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE 24GX0.75IN INSYTE AUTOGUARD DEVICE FROM LOT NUMBER 3121182. IN ADDITION, FOUR PHOTOGRAPHS WERE SUBMITTED WHICH DISPLAYED A PARTIALLY RETRACTED NEEDLE. THE NEEDLE HUB APPEARS TO BE STUCK AT THE INTERFACE BETWEEN THE GRIP AND THE BARREL, WHICH PREVENTED FULL NEEDLE RETRACTION. THE PHYSICAL SAMPLE WAS RECEIVED FULLY RETRACTED. FURTHER OBSERVATIONS SHOW THAT THE UNIT WAS USED AND THE SHIELD (GRIP/BARREL) THAT HOUSES THE NEEDLE IS DAMAGED. THE DAMAGE APPEARS TO BE A FLASH OR A DENT AT THE INTERFACE BETWEEN THE GRIP AND BARREL THAT RESTRICTS THE INNER DIAMETER OF THE SHIELD. THE NEEDLE WAS RE-ENGAGED AND UPON PRESSING THE SAFETY BUTTON, THE NEEDLE HUB GOT STUCK AT THE DAMAGED AREA OF THE SHIELD. THE DAMAGE ON THE SHIELD EXHIBITED NO MARKS OR IMPRESSIONS THAT WOULD INDICATE PHYSICAL FORCE WAS APPLIED FROM THE EXTERNAL SURFACE OF THE UNIT. THE DAMAGE WAS NOTED WITHIN THE BARREL. THE REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED FOR A NEEDLE SHIELDING FAILURE. DURING MANUFACTURING, DAMAGE TO THE GRIP MAY OCCUR DUE TO A MISALIGNMENT WHILE PLACING THE BARREL ON TOP OF THE GRIP. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    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, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT NEEDLE RETRACTION FAILURE. WHEN THE PERIPHERAL INTRAVENOUS NEEDLE WAS REPLACED IN THE HOSPITAL WARD, THE SAFETY FUNCTION DID NOT WORK, AND THE NEEDLE COULD NOT BE RETRACTED. BDJ CONFIRMED THE NEEDLE WAS NOT RETRACTED THOUGH THE SAFETY BUTTON WAS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675263 BD IAG BC PRO GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3121182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown