BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 25CM

    MDR report key: 16089825 · Received January 3, 2023

    Report

    Report Number
    0001625425-2023-00918
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 4, 2022
    Report Date
    February 13, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    OAJ
    UDI-DI
    00886333000159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE SAMPLE HAS BEEN RECEIVED AND REVIEWED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED, AND NO DEVIATIONS AND NON-CONFORMANCES WERE RECORDED. A REVIEW OF RETURNED PRODUCT FROM THE CUSTOMER WAS PERFORMED AND VISUALLY INSPECTED. THE SAMPLE RETURNED FROM THE CUSTOMER HAD THE LOCKING STRING BROKEN AND THE COMPLAINT WAS CONFIRMED. PACKAGE WAS OPEN AND SNAP OFF TAB AND STRING WAS LOOSE INSIDE THE PACKAGE. THE MOST PROBABLE ROOT CAUSE COULD BE THAT USER USED EXCESSIVE FORCE OR IMPROPER ANCHOR DURING THE PROCEDURE. THE TRO-CAR NEEDLE COULD HAVE ADVANCED TO THE ON POSITION AND CUT/DAMAGED THE STRING. SINCE THE BREAKAGE COULD BE DUE TO AN EVENT WITHIN THE USER ENVIRONMENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE PATIENT'S LIVER ABSCESS WAS PUNCTURED AND DRAINED, AND THE CATHETER WAS EXTUBATED NOW. THE DRAINAGE TUBE WAS PULLED OUT SMOOTHLY, BUT THE LEAD WAS NOT BROUGHT OUT SMOOTHLY. THE SURGEON WAS ASKED TO ASSIST IN DIAGNOSIS AND TREATMENT. THE RESISTANCE WAS GREAT WHEN TRYING TO PULL THE LEAD FOR MANY TIMES. FINALLY, THE LEAD WAS PARTIALLY BROKEN AND SOME REMAINED IN THE PATIENT'S BODY.

    Description of Event or Problem · 0

    THE PATIENT'S LIVER ABSCESS WAS PUNCTURED AND DRAINED, AND THE CATHETER WAS EXTUBATED NOW. THE DRAINAGE TUBE WAS PULLED OUT SMOOTHLY, BUT THE LEAD WAS NOT BROUGHT OUT SMOOTHLY. THE SURGEON WAS ASKED TO ASSIST IN DIAGNOSIS AND TREATMENT. THE RESISTANCE WAS GREAT WHEN TRYING TO PULL THE LEAD FOR MANY TIMES. FINALLY, THE LEAD WAS PARTIALLY BROKEN AND SOME REMAINED IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146272 SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 25CM SKATER OAJ ARGON MEDICAL DEVICES 755108025 11421909 00886333000159
    1606476 SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 25CM SKATER OAJ ARGON MEDICAL DEVICES 755108025 11421909 00886333000159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R