BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AIG BC PRO GLOBAL

    MDR report key: 20540988 · Received October 27, 2024

    Report

    Report Number
    1710034-2024-01205
    Event Type
    Malfunction
    Date Received
    October 27, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810338
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    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

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381023 AND LOT NUMBER 4141582. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IAG BC PRO GLOBAL CATHETER TIP IS JAGGED/ROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER DESCRIBED EVENT: WHEN THE CANNULA IS INSERTED INTO THE VEIN, THEY SEE THE FLUSH BUT THEN GETS STUCK AND CANNOT BE FURTHER ADVANCED. THE TIP OF THE CATHETER IS NOT SMOOTH -IT IS JAGGED/ROUGH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680198 BD AIG BC PRO GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4141582 00382903810338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown