BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET® PARADIGM®

    MDR report key: 11751337 · Received April 30, 2021

    Report

    Report Number
    3003442380-2021-00232
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Report Date
    March 29, 2022
    Product Code
    FPA
    UDI-DI
    05705244017436
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON 24-MAR-2022 IV: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE THE UNIQUE IDENTIFIER (UDI) NUMBER AND AWARENESS DATE. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, THE INFUSION SET'S TUBING DETACHED FROM THE FROM THE QUICK RELEASE CONNECTOR. THE SITE LOCATION WAS PATIENT'S ABDOMEN. MOREOVER, THE INFUSION WAS BEING USED FOR LESS THAN 24 HOURS. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT WAS UNSURE WHETHER THERE WAS ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021 , THE INFUSION SET'S TUBING DETACHED FROM THE FROM THE QUICK RELEASE CONNECTOR. THE SITE LOCATION WAS PATIENT'S ABDOMEN. MOREOVER, THE INFUSION WAS BEING USED FOR LESS THAN 24 HOURS. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT WAS UNSURE WHETHER THERE WAS ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653836 QUICK-SET® PARADIGM® UNO QUICK-SET 60/6 SC1 MECA FPA MMT-399A UNKNOWN 05705244017436

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown