BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL WING

    MDR report key: 21640867 · Received March 19, 2025

    Report

    Report Number
    1710034-2025-00426
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 12, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903829446
    PMA / PMN Number
    UNK
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: 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 382944 AND LOT NUMBER 4298108. 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

    ADDITIONAL INFORMATION OF FA#.

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DESCRIPTION OF THE FACTS, CIRCUMSTANCES AND MEANS USED: THE AUTO-GUARD DEVICE DOES NOT WORK OR RETRACTS VERY SLOWLY. MEASURES TAKEN: 1 YES. FREQUENCY: 5 VERY PROBABLE (MORE THAN ONCE A WEEK). DESCRIPTION OF THE CONSEQUENCES: RISK OF NEEDLE STICK AND SPLASHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565322 BD IAG BC PRO GLOBAL WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4298108 00382903829446

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown