BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPILONG II

    MDR report key: 20892442 · Received December 10, 2024

    Report

    Report Number
    9611612-2024-00033
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    October 2, 2024
    Report Date
    March 11, 2024
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    OGE
    UDI-DI
    04048223119501
    PMA / PMN Number
    K060311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT TOOK PLACE IN ITALY. PLACEHOLDERS WERE INSERTED UNDER POINT H6, CODES B, C AND D, WHICH WERE NOT VERIFIED, AS THE INITIAL REPORT COULD ONLY BE PACKAGED IN THIS FORM IF THEY WERE FILLED IN. IN THIS FINAL REPORT, THESE PLACEHOLDERS FROM THE FIRST REPORT WERE CHANGED AFTER THE ROOT CAUSE ANALYSIS. THIS CONCERNS CODES B, C AND D. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Additional Manufacturer Narrative · 0

    COMPLAINT TOOK PLACE IN ITALY. ALL CODES MUST BE FILLED IN FOR THE INITIAL REPORT, ALTHOUGH THE INITIAL REPORT DID NOT PREVIOUSLY REQUIRE THE B, C AND D CODES. OTHERWISE THE PACKING OF THE PARCELS WILL NOT WORK. IN THE SUBSEQUENT FU1 WITH THE DETERMINED TEST RESULTS, THESE CAN CHANGE AGAIN! THE FAILURE MODE WAS ONLY SENT TO US ON 2024-12-03 AND IS CURRENTLY STILL BEING CHECKED - ERROR ANALYSIS. THE CURRENT PROCESSING STATUS DOES NOT YET CONTAIN THE COMPLETE ANALYSIS AND TEST RESULTS, WHICH WILL ONLY BE TRANSMITTED WITH THE SUBSEQUENT FU1.

    Description of Event or Problem · 0

    IRN# (B)(4) INCIDENT OCCURRED IN ITALY: TEXT FROM THE FIRST COMPLAINT WITH INSUFFICIENT DESCRIPTION: ACCIDENTAL DURAL PUNCTURE WITH A DEVICE THAT HAS SHOWN, AFTER USE, A WELDING DEFECT, THIS DEFECT HAS BEEN OBSERVED IN OTHER DEVICES WITH THE SAME LOT. OF THE PATIENT WE KNOW HAS HAD A WORSENING OF HEALTH STATUS AND PROLONGED ILLNESS AFTER HOSPITAL DISCHARGE. PAJUNK WAS ASKED TO DESCRIBE THE INCIDENT AND THE PRODUCT DEFECT IN MORE DETAIL / RESULT: ON (B)(6) 2024, PAJUNK GMBH RECEIVES THE INFORMATION VIA MOVI THAT, THE SUBJECT OF THE OFFICIAL REPORT WAS LESS SERIOUS THAN EXPECTED AND THE ACTUAL NEEDLE DEFECT WAS ALSO BADLY DESCRIBED. PROBLEM IS THAT THERE IS A LEAKAGE IN THE PLASTIC HUB OF THE TUOHY II". NOTE: REJECTED SAMPLE WILL BE DELIVERED ON (B)(6) 2024.

    Description of Event or Problem · 0

    IRN# (B)(4) INCIDENT OCCURRED IN ITALY: TEXT FROM THE FIRST COMPLAINT WITH INSUFFICIENT DESCRIPTION: ACCIDENTAL DURAL PUNCTURE WITH A DEVICE THAT HAS SHOWN, AFTER USE, A WELDING DEFECT, THIS DEFECT HAS BEEN OBSERVED IN OTHER DEVICES WITH THE SAME LOT. OF THE PATIENT WE KNOW HAS HAD A WORSENING OF HEALTH STATUS AND PROLONGED ILLNESS AFTER HOSPITAL DISCHARGE. PAJUNK WAS ASKED TO DESCRIBE THE INCIDENT AND THE PRODUCT DEFECT IN MORE DETAIL / RESULT: ON (B)(6) 2024, PAJUNK GMBH RECEIVES THE INFORMATION VIA MOVI THAT, THE SUBJECT OF THE OFFICIAL REPORT WAS LESS SERIOUS THAN EXPECTED AND THE ACTUAL NEEDLE DEFECT WAS ALSO BADLY DESCRIBED. PROBLEM IS THAT THERE IS A LEAKAGE IN THE PLASTIC HUB OF THE TUOHY II". NOTE: REJECTED SAMPLE WILL BE DELIVERED ON 2024-12-03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2533167 EPILONG II EPILONG II TUOHY_EPIDURAL ANESTHESIA KIT OGE PAJUNK GMBH MEDIZINTECHNOLOGIE 033115201-51 1548 04048223119501

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Unknown Other