BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP CHANNEL DRAIN 24 FR HUBLESS

    MDR report key: 10324400 · Received July 26, 2020

    Report

    Report Number
    8030107-2020-00019
    Event Type
    Malfunction
    Date Received
    July 26, 2020
    Date of Event
    July 4, 2020
    Report Date
    July 23, 2020
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    OTK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE DID NOT RECEIVE THE ACTUAL SAMPLE FOR THIS COMPLAINT SO IT IS UNCLEAR IF THE CUSTOMER STATES THAT THERE WAS OTHER KIND OF DRAIN AT THE WOUND (NOT FLUTED) OR THE 24FR DRAIN HAD NO FLUTED AREA. WE EVALUATED THE RETAIN SAMPLE FROM THE SAME BATCH P1840460. THE PART IS CORRECT 24FR FLUTED DRAIN, IT MATCHES ITS SPECIFICATION. THIS DRAIN CONSISTS FROM TUBING PART WHICH PASSES INTO FLUTED PART. THE POSSIBLE EXPLANATION OF THE PROBLEM FACED BY THE CUSTOMER MIGH BE, THAT SOMETIMES SURGEONS SHORTEN THE FLUTED PART OF THESE DRAINS BY CUTTING IT. IN THIS CASE, THE FLUTED PART MIGHT BE CUT TOO HIGH, SO WHEN THE DRAIN WAS REMOVED FROM THE PATIENT, PROBABLY BY OTHER PERSON THEN THE ONE WHO INSERTED IT, THEY FOUND ONLY THE TUBINE PART WITHOUT FLUTES. WE WERE UNABLE TO CONNECT THE DESCRIBED FAILURE TO OUR PRODUCTION PROCESS; MOST LIKELY, THE REASON IS RELATED TO THE END USER. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED; NO CAPA IS REQUIRED IN THIS CASE.

    Description of Event or Problem · 1

    SO THIS WEEKEND WE HAD A PATIENT THAT WAS BROUGHT TO SURGERY AND HAD THE DRAINS FROM OUR PACK INSERTED. THIS PATIENT WAS BROUGHT BACK TO SURGERY FOR BLEEDING LATER THAT DAY AND IT WAS NOTICED THAT THE BLAKE DRAIN WAS NOT FLUTED. THIS OBVIOUSLY WOULD HAVE PREVENTED BLOOD/FLUIDS FROM BEING EVACUATED AND POTENTIALLY DELAYED THE PATIENTS RETURN TO SURGERY. WHERE WAS THE ANATOMICAL LOCATION OF THE DRAIN? MEDIASTINAL SPACE. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? CHEST EXPLORATION FOR A HEMATOMA. THE PATIENT WAS POST CABG BY 10 DAYS. DRAINS WERE PUT IN DURING THIS PROCEDURE. WAS IT CABG ONLY? PLEASE CONFIRM IF THE BLEEDING WAS DUE TO THE BLAKE DRAIN NOT BEING FLUTED MAKING THE BLOOD BUILD UP? I CANNOT CONFIRM THAT THE BLEEDING WAS DUE TO THE BLAKE DRAIN NOT BEING FLUTED BUT I CAN CONFIRM THAT THE FLUID WAS NOT ALLOWED TO DRAIN DUE TO THE BLAKE DRAIN NOT BEING FLUTED. ASIDE FROM THE INITIAL SURGERY, WAS THERE ANY ADDITIONAL MEDICAL CARE OR PRESCRIPTIVE MEDICATION GIVEN TO THE PATIENT DUE TO THE DISCOVERY OF MISSING FLUTING IN THE TUBING? IF YES, WHAT WAS THE ADDITIONAL MEDICAL CARE PROVIDED? PLEASE DESCRIBE THE PATIENT WAS BROUGHT BACK FIVE HOURS LATER WITH A LITER OF BLOOD IN THEIR CHEST. WAS A NEW DRAIN INSERTED? INSTEAD OF THE 24FR BLAKE DRAINS, THE MD PUT IN 32FR CHEST TUBES. WHAT WAS THE ADDITIONAL PRESCRIPTIVE MEDICATION GIVEN? PLEASE LIST NAME OF MEDICATION THE PATIENT CAME TO THE OR ON DRIPS, NO ADDITIONAL MEDICATIONS WERE ADDED TO WHAT INITIALLY WAS THERE. DO YOU STILL HAVE THE SAMPLE OF THE REPORTED PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS? NO. IF NO, MAY WE KNOW WHY THE SAMPLE IS UNAVAILABLE? (I.E. DISCARDED, ETC[?]) THE MD CUT THE DRAIN TO REMOVE IT AND THE SURGICAL TECH DISCARDED IT. HOW IS THE PATIENT DOING NOW? THE PATIENT IS DOING FAIRLY WELL. PLEASE ANSWER THESE ADDITIONAL QUESTIONS AS REQUESTED BY THE FDA: AGE (REQUESTED BY FDA) (B)(6). GENDER (REQUESTED BY FDA) MALE. WEIGHT (REQUESTED BY FDA) 114.3 KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788547 JP CHANNEL DRAIN 24 FR HUBLESS JP CHANNEL DRAIN 24 FR OTK DEGANIA SILICONE LTD JP-2234 P1840460

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention