BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP

    MDR report key: 19580951 · Received June 21, 2024

    Report

    Report Number
    3006575797-2024-00372
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 20, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FPA
    UDI-DI
    00814371020570
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PRODUCT HAD NOT BEEN RETURNED, THEY WERE REQUESTED TO BE RETURN FOR FURTHER INVESTIGATION. TESTING RESULTS WERE REVIEWED. IT WAS DISCOVERED THAT THERE WERE DISCREPANCIES IN THE TEST RECORDS. NCR #2024-018 HAD BEEN INITIATED TO ADDRESS THE DISCREPANCIES. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE AFFECTED PRODUCT INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON 05/31/2024, ZYNO RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT THE GREEN FILTER INSERT (WHICH HAD THE FILTER COVER ON IT) ABOVE THE CHAMBER WAS NOT SECURED IN ANY WAY AND COULD BE PULLED OUT EASILY. NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281028 ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP IV ADMISTRATION SET FPA ZYNO MEDICAL, LLC BX70072 2207006 00814371020570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown