BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 20105310 · Received August 30, 2024

    Report

    Report Number
    3003442380-2024-23134
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 1, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1955788 - MDR 3003442380-2024-23134 - DEVICE 2 OF 5.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, THE PATIENT FACED ISSUE OF 5 INFUSION SETS BEING KINKED ON 10-JUL-2024. THE SETS WAS FOUND TO BE KINKED 3 OR MORE HOURS AFTER INSERTION, AFTER BEING IN USE FOR 5 HOURS. THE SITE OF INSERTION WAS LOCATED AT ABDOMEN. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803674 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female