BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 19864727 · Received July 30, 2024

    Report

    Report Number
    2210968-2024-07844
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    August 25, 2023
    Report Date
    August 21, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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.

    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. 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 (BLAKE DRAIN UNKNOWN) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: INFECTIOUS COMPLICATIONS, SURGICAL SITE INFECTION, REMOTE INFECTION, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2023) 408:333. HTTPS://DOI.ORG/10.1007/S00423-023-03080-3. 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: FAILURE OF PERITONEAL LAVAGE TO PREVENT OPERATIVE SITE INFECTION AND PERITONEAL TUMOR RECURRENCE IN PANCREATIC SURGERY. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE EFFICACY OF INTRAOPERATIVE PERITONEAL LAVAGE IN REDUCING POSTOPERATIVE INFECTIOUS COMPLICATIONS OF PANCREATIC SURGERY AND EVALUATE FREQUENCY OF PERITONEAL RECURRENCE AFTER PANCREATECTOMY FOR MALIGNANT DISEASES. BETWEEN 2019 TO 2021, A TOTAL OF 104 PATIENTS UNDERWENT OPEN PANCREATIC SURGERY. AMONG THEM, PANCREATODUODENECTOMY (PD) WAS PERFORMED IN 62, DISTAL PANCREATECTOMY (DP) IN 37, AND TOTAL PANCREATECTOMY (TP) IN 5. ACCORDINGLY, PERITONEAL LAVAGE WAS PERFORMED FOR 65 PATIENTS (33 MALE AND 32 FEMALE; MEAN AGE OF 72 (40-90) YEARS) AND NOT PERFORMED FOR 39 PATIENTS (24 MALE AND 15 FEMALE; MEAN AGE OF 73 (47-87) YEARS). DURING PD, 2 CLOSED SUCTION DRAINS (J-VAC DRAIN, JOHNSON & JOHNSON, SOMERVILLE, NJ, USA) WERE PLACED NEAR THE HEPATOJEJUNOSTOMY AND PANCREATOJEJUNOSTOMY IN BOTH LAVAGE AND NON-LAVAGE GROUPS. TWO CLOSED-SUCTION DRAINS ALSO WERE PLACED NEAR THE CUT END OF THE PANCREAS AND THE LEFT SUBPHRENIC SPACE DURING DP. CLOSED-SUCTION DRAINS WERE PLACED NEAR THE HEPATOJEJUNOSTOMY AND LEFT SUBPHRENIC SPACE DURING TP. REPORTED COMPLICATIONS INCLUDE INFECTIOUS COMPLICATIONS (N=29), SURGICAL SITE INFECTION (N=21), AND REMOTE INFECTION (N=11). IN CONCLUSION, INTRAOPERATIVE LAVAGE DID NOT PREVENT SURGICAL SITE INFECTION OR PERITONEAL RECURRENCE OF PANCREATOBILIARY CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253459 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention