BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NSYTE AUTOGUARD WINGED

    MDR report key: 19824485 · Received July 25, 2024

    Report

    Report Number
    1710034-2024-00771
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 2, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    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: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH CATHETER DEFECTIVE / DAMAGED LOT # 3248257 REGARDING ITEM 381912. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394601 AND LOT NUMBER 3093242. 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. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NSYTE AUTOGUARD WINGED CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THREE DIFFERENT CATHLONS THIS MORNING THAT SPLIT WHEN THE CHILD WAS PRICKED, CRACKS NOT VISIBLE BEFORE PRICKING PAIN AND STRESS FOR THE CHILD, DAMAGED VEINS AND +++ DIFFICULTY IN RE-DRAWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408952 BD NSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3248257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown