BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-T® PARADIGM®

    MDR report key: 8623186 · Received May 20, 2019

    Report

    Report Number
    3003442380-2019-01479
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Product Code
    FPA
    UDI-DI
    05705244005778
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE TUBING FROM HER INFUSION SET BECAME DETACHED FROM THE SITE WHEN SHE ROLLED OVER OR STRETCHED OUT WHILE SLEEPING. SHE USUALLY CLIPPED THE PUMP TO HER CLOTHES WHILE SLEEPING BUT THE NIGHT BEFORE THIS REPORT, SHE PUT IT IN HER SHORTS POCKET AND WOKE UP WITH IT UNDER HER BODY. THE SITE LOCATION WAS AT THE UPPER LEFT THIGH. THE INFUSION HAD BEEN IN USE FOR MORE THAN ONE DAY AND THE INFUSIONS WERE STORED IN THE CENTRALLY HEATED BATHROOM. THERE WAS STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416443 SURE-T® PARADIGM® CONTACT DETACH G29 60/6 PCC FPA 5234192 05705244005778

    Patients

    Seq Age Sex Outcome Treatment
    1