BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC TENDERLINK I

    MDR report key: 4231677 · Received October 10, 2014

    Report

    Report Number
    8021545-2014-00004
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    May 26, 2014
    Report Date
    October 10, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH RECORDS AND REFERENCE SAMPLES WERE INSPECTED AND NO DEVIATIONS WERE FOUND. THIS IS A NEWLY SEEN FAILURE AND WHILST THE RISK MGMT DOCUMENTS HAVE ASSESSED THIS TYPE OF FAILURE, IT WILL BE INVESTIGATED IN A CAPA. EVALUATION SUMMARY: A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED DEVICE (1). IN THE VISUAL INSPECTION FOUND DAMAGES THE SOFT CANNULA WAS ABOVE OF THE CLEAR WINDOW AND KINKED IN THE TIP. THE FLOW AND LEAK TESTS WERE IN ACCORDANCE WITH SPECIFICATIONS. THE NEEDLE TEST CANNOT BE PERFORMED DUE TO THE INTRODUCER NEEDLE WAS NOT RETURNED. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED IN THE CLEAR WINDOW OF THE ADHESIVE TAPE AND TESTED FOR NEEDLE, FLOW AND LEAK. ALL TESTS RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 5053304 WAS VERIFIED AND FOUND IT WITHIN SPECIFICATIONS. .

    Description of Event or Problem · 1

    THE MD BELIEVES THAT HE IDENTIFIED A DESIGN WEAKNESS BECAUSE HIS PT EXPERIENCED REPEATED TIMES A PROBLEM WITH THE CANNULA, WHICH DID NOT REMAIN IN THE SUBCUTANEOUS TISSUE ALTHOUGH THE PLASTER SHOULD FIX THE CANNULA. THE CANNULA LUXATED OUT OF THE SKIN THROUGH THE HOLE IN THE PLASTER AND ENDED UP OUTSIDE THE PT ABOVE THE PLASTER. ACCORDING TO HIS OPINION, THE CANNULA DESIGN (HORIZONTAL FIXATION AT THE CONNECTOR) IS THE DESIGN PROBLEM, IN ADDITION THE PLASTER IS NOT TEARPROOF AND THE HOLE FOR THE CANNULA IS TOO LARGE. THE PT EXPERIENCED SEVERE HYPERGLYCEMIA WITHIN A FEW HOURS. THAT BEARS THE RISK (ESPECIALLY AT NIGHT TIME) FOR KETOACIDOSIS AND IS A 'VITAL RISK' FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639078 AC TENDERLINK I COMFORT FPA UNOMEDICAL A/S 4541642001 5053304

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention