BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JP CHANNEL DRAIN 10 FR HUBLESS WITH TROCAR

    MDR report key: 10337036 · Received July 29, 2020

    Report

    Report Number
    8030107-2020-00020
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 29, 2020
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    OTK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE DID NOT RECEIVE THE ACTUAL DRAIN FOR THIS COMPLAINT FOR OUR EVALUATION. THE REASON FOR THE DRAIN TO ENTIRELY SLIP INTO THE WOUND MIGHT BE ITS BREAKAGE NEAR THE SURGICAL EXIT SITE OR THE DRAIN COULD GET INTO THE PATIENT BECAUSE IT WAS CUT DURING USE LEAVING SHORT PIECE OF 10 CM OUTSIDE THE SURGICAL EXIT SITE. WE EVALUATED THE BATCH HISTORY RECORDS OF THIS BATCH, PARTICULARLY THE RESULTS OF IN-PROCESS TENSILE STRENGS TESTS (TEAR TESTS) AND THE RESULTS WERE WELL ABOVE THE REQUIRED MINIMUM, SHOWING THAT THE DRAIN WAS NOT WEAKENED AND MOST LIKELY THE REASON FOR THE DRAIN TO GET INSIDE THE PATIENT, IS NOT A BREAKAGE/TEAR OF THE DRAIN FOLLOWING ANY MANUFACTURING ISSUE. WE CONCLUDE THAT MOST LIKELY THAT THE REASON FOR DRAIN TO SLIP INTO SURGICAL WOUND IS RELATED TO ITS USE (SHORT CUT) AND NOT TO MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    PATIENT WENT FOR A PROCEDURE VIDEO LAPAROSCOPIC CHOLECYSTECTOMY ON THE (B)(6) 2020. CHANNEL DRAIN WAS INSERTED TO DRAIN THE WOUND. ON THE (B)(6) 2020, SURGEON MADE A CLINICAL DECISION TO CUT THE DRAIN AND LEFT A LENGTH OF 10 CM FROM THE SURGICAL EXIT SITE TO THE DRAINAGE BOTTLE. AT 10 PM ON THE SAME DAY, THE WARD NURSE NOTICED THAT THE DRAIN IS NO LONGER SEEN. AN X-RAY WAS ORDERED AND FOUND THE DRAIN IS INSIDE THE PATIENT'S BODY. A SURGERY WAS PERFORMED THE SAME DAY OF THE X-RAY TO REMOVE THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802236 JP CHANNEL DRAIN 10 FR HUBLESS WITH TROCAR JP CHANNEL DRAIN 10FR OTK DEGANIA SILICONE LTD JP-2227 P1836120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention