BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER SINGLE STEP DRAINAGE SET-LOCKING 8F X 25CM

    MDR report key: 16277517 · Received February 1, 2023

    Report

    Report Number
    0001625425-2023-00952
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    September 5, 2022
    Report Date
    February 28, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    OAJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE 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. VISUAL INSPECTION OF THE SAMPLE RETURNED FROM THE CUSTOMER FOUND NO DAMAGE TO THE PRODUCT. FUNCTIONAL TESTING OF THE DEVICE RETURNED FROM THE CUSTOMER CONFIRMED THAT GUIDEWIRE 0.035" PASSED THROUGH THE DRAINAGE SKATER TUBE WITHOUT ANY ISSUE. PRODUCT COMPLAINT MODE COULD NOT BE DUPLICATE DURING THE EVALUATION AND THE COMPLAINT WAS NOT CONFIRMED. THE COMPLAINT WAS NOT CONFIRMED, SO NO FURTHER EVALUATION NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT WHO UNDERGOES AN EVACUATING THORACENTESIS ACCORDING TO MEDICAL ORDER, WHEN INTRODUCING THE CATHETER INTO THE PLEURAL SPACE, NO FLUID IS OBTAINED WHEN ASPIRATING, THE DOCTOR VERIFIES THE LOCATION OF THE CATHETER AND IT IS IN THE CORRECT POSITION, REMOVES THE DEVICE AND REASSEMBLES IT , WHEN TRYING TO INTRODUCE IT, THE ULTRASOUND SHOWS ABUNDANT SUBCUTANEOUS EMPHYSEMA IN THE SOFT TISSUES OF THE THORAX, IT IS NOT POSSIBLE TO PASS THE CATHETER BACK TO THE PLEURAL CAVITY. PNEUMOTHORAX IS SUSPECTED.

    Description of Event or Problem · 0

    PATIENT WHO UNDERGOES AN EVACUATING THORACENTESIS ACCORDING TO MEDICAL ORDER, WHEN INTRODUCING THE CATHETER INTO THE PLEURAL SPACE, NO FLUID IS OBTAINED WHEN ASPIRATING, THE DOCTOR VERIFIES THE LOCATION OF THE CATHETER AND IT IS IN THE CORRECT POSITION, REMOVES THE DEVICE AND REASSEMBLES IT , WHEN TRYING TO INTRODUCE IT, THE ULTRASOUND SHOWS ABUNDANT SUBCUTANEOUS EMPHYSEMA IN THE SOFT TISSUES OF THE THORAX, IT IS NOT POSSIBLE TO PASS THE CATHETER BACK TO THE PLEURAL CAVITY. PNEUMOTHORAX IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286609 SKATER SINGLE STEP DRAINAGE SET-LOCKING 8F X 25CM SKATER OAJ ARGON MEDICAL DEVICES 756508025E 11421913
    752226 SKATER SINGLE STEP DRAINAGE SET-LOCKING 8F X 25CM SKATER OAJ ARGON MEDICAL DEVICES 756508025E 11421913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O