BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDLINE

    MDR report key: 20958721 · Received December 17, 2024

    Report

    Report Number
    3008737795-2024-00021
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    April 11, 2024
    Report Date
    December 17, 2024
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    PND
    PMA / PMN Number
    K173114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD AND ASSOCIATED CATHETER RECEIVING INSPECTION RECORD WERE REVIEWED AND NO ISSUES OR DEVIATIONS WERE OBSERVED. THE PRODUCT MET SPECIFICATIONS AFTER COMPLETION OF THE MANUFACTURING PROCESS. THE LEAK IN THE CATHETER SHAFT WAS CONFIRMED BUT THE ROOT CAUSE COULD NOT BE ESTABLISHED. BASED ON THE INFORMATION PROVIDED THAT THE CATHETER WAS ABLE TO INFUSE AND WITHDRAWAL FLUID DURING PRE-INSERTION TESTING BY THE CLINICIAN, IT IS POSSIBLE THAT THE CATHETER WAS KINKED DURING INSERTION INTO THE PATIENT LEADING TO THE LEAK. THE COMPLAINT IS CONSIDERED REPORTABLE TO THE FDA DUE TO SIMILARLY MARKETED DEVICES. THIS COMPLAINT IS FOR PRODUCT CODE "PFM3SML20P" , FOR FOREIGN COUNTRIES AND PRODUCT CODE "PFM3SML20" IS AN IDENTICAL PRODUCT AND MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    PATIENT HAD DEVICE INSERTED IN CLINIC, ON PRE-INSERTION OF DEVICE CHECK AND ON INITIAL TESTING THE LINE WAS FLUSHING AND WITHDRAWING BLOOD WITHOUT ISSUE. PATIENT THEN ATTENDED INFUSION CLINIC AND ON ADMINISTRATION OF TREATMENT AN HOUR LATER THE LINE APPEARED TO HAVE FRACTURED AT THE TOP OF THE WINGS OF THE DEVICE AND WAS VISIBLY KINKED. A SMALL LEAK WAS EVIDENT ON FLUSHING THE DEVICE. PATIENT WAS UNWILLING TO PROCEED WITH A FURTHER MIDLINE INSERTION THAT RESULTED IN REPEATED CANNULATION. PATIENT WAS PLACED AT RISK OF INFECTION AND AIR EMBOLISM WHEN THE LINE INITIALLY FRACTURED. THE MIDLINE WAS REMOVED AFTER IT FRACTURED WITHIN AN HOUR OF LINE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259031 MIDLINE 3F X 20CM SINGLE LUMEN MIDLINE PND PFM MEDICAL, INC. PFM3SML20P 2307-033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention