BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE COMFORT

    MDR report key: 3599723 · Received December 4, 2013

    Report

    Report Number
    8021545-2013-00012
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Date of Event
    September 16, 2013
    Report Date
    November 29, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K120872
    Removal / Correction Number
    8021545-11/19/2013-0006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH ASANTE SOLUTIONS, THE DISTRIBUTOR OF THE INFUSION SET. THE INTERNAL REFERENCE NUMBER FOR THIS COMPLAINT AT ASANTE SOLUTION IS (B)(4).THIS MDR REPORT HAS BEEN MADE SINCE THIS EVENT HAS LED TO A RECALL. THIS INCIDENT HAS ALREADY BEEN REPORTED TO THE FDA IN THE ASR REPORT FOR Q3 2013. IN NOVEMBER 2013, A VOLUNTARY PRODUCT RECALL FOR THE DEVICE WAS INITIATED AND REPORTED TO THE FDA UNDER REPORT NO (B)(4). EVALUATION SUMMARY: USED DEVICE: NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. REFERENCE SAMPLES: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING-ASANTE CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER SENT EMAIL STATING "I HAD MY TUBE BREAKING OFF FROM THE PUMP THIS WEEKEND. I REATTACHED A NEW TUBING TO THE CARTRIDGE AND COMPLETED A MANUAL PRIME. IT HAS MADE ME QUESTION THE STURDINESS OF THE INFUSION SETS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629794 ASANTE COMFORT ASANTE COMFORT FPA UNOMEDICAL A/S 4123-5 0230118

    Patients

    Seq Age Sex Outcome Treatment
    1