BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CM

    MDR report key: 16372209 · Received February 14, 2023

    Report

    Report Number
    0001625425-2023-00967
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    February 6, 2023
    Report Date
    February 14, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    OAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE PRODUCT EXPERIENCE REPORT, THERE WAS NO SAMPLE TO BE RETURNED. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT SUCH EVIDENCE, THIS COMPLAINT COULD NOT BE CONFIRMED AND DETERMINING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS DIFFICULTY WHEN INSERTING THE DEVICE INTO THE PATIENT, IT IS NOT POSSIBLE TO PERFORM DIRECT PUNCTURE AND WITH THE NEED TO USE OTHER DEVICES TO INSERT THE CATHETER. IT HAS HAPPENED SEVERAL TIMES, REPORTS THE INSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703426 SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CM SKATER OAJ ARGON MEDICAL DEVICES 756508025 11442606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O