BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL YEL 24GA X .75IN

    MDR report key: 18573531 · Received January 24, 2024

    Report

    Report Number
    1710034-2024-00030
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 5, 2024
    Report Date
    February 28, 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

    INVESTIGATION SUMMARY: 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 381012 AND LOT NUMBER 3121182. 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.

    Additional Manufacturer Narrative · 0

    B3: THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD EXPERIENCED NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT SAFETY MECHANISM DOES NOT WORK. ACCORDING TO THE CUSTOMER REPORT THE NEEDLE DOES NOT RETRACT INTO THE CASE WHEN THE SAFETY MECHANISM ACTIVATION BUTTON IS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056574 BD IAG BC PRO GLOBAL YEL 24GA X .75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3121182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown