BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

    MDR report key: 6087751 · Received November 8, 2016

    Report

    Report Number
    2210968-2016-14808
    Event Type
    Injury
    Date Received
    November 8, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHERE WAS THE PSEUDOANEURYSM LOCATED? DOES THE SURGEON OPINE THAT THE PSEUDOANEURYSM WAS CAUSED BY THE DRAIN? WHERE WAS THE HEMATEMESIS? WHAT WAS THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? PLEASE PROVIDE PATIENT DEMOGRAPHIC INFO: AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT IS THE PATIENT¿S CURRENT STATUS? WHAT IS THE LOT NUMBER?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON UNKNOWN DATE AND THE DRAIN WAS IMPLANTED FOR PANCREATICOJEJUNAL ANASTOMOSIS. THE BLACK MARK ON THE DRAIN TUBE WAS LOCATED AT EPIDERMIS, INSTEAD OF AT THE BEGINNING POINT OF THE ANASTOMOTIC GROOVE INSIDE THE PATIENT. AFTER THE PROCEDURE, THE AMYLASE VALUE WAS UNREMARKABLE. FIVE DAYS FOLLOWING THE PROCEDURE, THE DRAIN TUBE WAS REMOVED AND THE PANCREATICOJEJUNAL ANASTOMOSIS SITE LOOKED UNREMARKABLE. IT WAS ALSO REPORTED THAT THE OTHER DRAIN TUBE WAS USED FOR CHOLANGIOJEJUNAL ANASTOMOSIS IN THE INDEX PROCEDURE AND NO COMPLICATIONS WERE REPORTED BEFORE AND AFTER ITS REMOVAL. HOWEVER, THERE WAS SOME BLOOD ON THE PANCREATICOJEJUNAL DRAIN TUBE AFTER THE DRAIN TUBE WAS REMOVED. A PSEUDOANEURYSM WAS FOUND AND DIAGNOSED AS SERIOUS AND WITH CAUSAL RELATIONSHIP TO THE DEVICE. FOUR WEEKS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED HEMATEMESIS. THE DOCTOR OPINED THAT HE HAD SOME SORT OF RECOGNITION THAT THE POSITION OF THE DRAIN TUBE MIGHT HAVE BEEN INCORRECT; THUS, THE PURPOSE OF INFORMATIONAL DRAINAGE WAS NOT ACCOMPLISHED IN ORDER TO DETECT PANCREATIC FLUID LEAKAGE. THE PATIENT IS CURRENTLY HOSPITALIZED IN THE ICU. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738256 ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BLAKE DRAIN