BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 19833163 · Received July 25, 2024

    Report

    Report Number
    2210968-2024-07672
    Event Type
    Death
    Date Received
    July 25, 2024
    Date of Event
    January 1, 2023
    Report Date
    July 25, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO FURTHER INFORMATION WILL BE PROVIDED WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF DETERMINED, WHAT WAS THE CAUSE OF DEATH? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATIONS : BMC SURGERY. VOL. 23:87 HTTPS://DOI.ORG/10.1186/S12893-023-01980-1 AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI: IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE : DRAIN FLUID AND SERUM AMYLASE CONCENTRATION RATIO IS THE MOST RELIABLE INDICATOR FOR PREDICTING POSTOPERATIVE PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY THE AIM OF THE STUDY WAS TO IDENTIFY THE SINGLE MOST ACCURATE INDICATOR RELATED TO DRAIN FUID AMYLASE STATUS OF POPF AFTER DP. THIS RETROSPECTIVE STUDY INCLUDED 140 PATIENTS WHO UNDERWENT DP FOR PANCREATIC DISEASE AT DEPARTMENT OF GASTROENTEROLOGICAL SURGERY IN GIFU UNIVERSITY HOSPITAL BETWEEN JANUARY 2010 AND OCTOBER 2022. IN THE HAND-SEWN CLOSURE GROUP, THE PANCREAS WAS RESECTED AFTER IDENTIFYING THE MAIN PANCREATIC DUCT, WHICH WAS LIGATED WITH A 3¿0 SILK SUTURE. THE STUMP OF THE REMNANT PANCREAS WAS CLOSED WITH VERTICAL MATTRESS SUTURES USING 5¿0 POLYPROPYLENE. ONE 19-FR. BLAKE SILICON DRAIN (JOHNSON & JOHNSON, INC. NEW BRUNSWICK, NJ, USA) WAS PLACED NEAR THE STUMP OF THE REMNANT PANCREAS. THE REPORTED COMPLICATIONS INCLUDED MORTALITY (N=2) AND POSTOPERATIVE PANCREATIC FISTULA (N=30). IN CONCLUSION, DSACR IS THE MOST RELIABLE INDICATOR OF DRAIN FUID AMYLASE STATUS FOR PREDICTING POPF AFTER DP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280648 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death