BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 19318433 · Received May 15, 2024

    Report

    Report Number
    3003442380-2024-01833
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Report Date
    July 24, 2024
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 2 OF 3.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING TESTS WERE COMPLETED FOR 10 REFERENCE SAMPLES AND 1 RETURNED USED DEVICE OF LOT 6004012: VISUAL INSPECTION AS (B)(4) CRITERIOS DE CATETER DOBLADO & CURVO (BENT & CURVED CATHETER CRITERIA). 10 REFERENCE SAMPLES VISUALLY INSPECTED AND NO DAMAGES OR BENT BUT IN 1 USED SET THE SOFT CANNULA WAS BENT AT THE TIP. (B)(4), FLOW TEST ON CUSTOMER COMPLAINTS (PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE), VERSION 10. 10 REFERENCE SAMPLES MET THE CRITERIA OF MINIMUM 80ML/MINUTE, BUT 1 USED SET WAS FOUND WITH THE P-CAP CONNECTOR NEEDLE CLOGGED (BY INSULIN). FLOW TEST: P1: 113, P2: 137, P3: 120, P4: 131, P5: 117, P6: 133, P7: 140, P8: 111, P9: 132, P10: 103.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET CANNULA BENT EVENTS ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR FEW HOURS. THE INSERTION SITE WAS AT ABDOMEN. 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.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358610 QUICK SET PARADIGM UNO QUICK-SET 60/6 SC1 MECA FPA 6004012 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown