BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL CATHETER KIT

    MDR report key: 18839708 · Received March 5, 2024

    Report

    Report Number
    3013886523-2024-00060
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 24, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780515616
    PMA / PMN Number
    K102589
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BACTISEAL CATHETER (ID 823072) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT WAS DISCARDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: "WE ARE INFORMED BY THE DEALER THAT THESE TWO PRODUCTS WERE NOT IMPLANTED INTO THE PATIENT ON (B)(6) 2024. ON (B)(6) 2024, THE PHYSICIAN WAS INTENDED TO IMPLANT MICRO CHPV UNITIZED (ID 823114) & CODMAN BACTISEAL CATHETER KIT (ID 823072) AND THEY HAD ALREADY OPEN THE DEVICE. WHILE DURING THE PROCEDURE, THE PHYSICIAN FOUND THERE WAS BIOGENIC DEPOSIT IN PATIENT¿S BRAIN, THEY SUSPECTED THAT THE PATIENT HAD INFECTION. THEREFORE, THEY STOPPED IMPLANTING THE PRODUCTS."

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3013886523-2024-00059. A FACILITY REPORTED A HAKIM VALVE (ID 823114 ) AND CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2024. AFTER 20 DAYS, IT WAS FOUND THAT HYDROCEPHALUS WAS NOT OBVIOUS WHILE THE PATIENT HAD INTRACRANIAL INFECTION UNDER COMPUTERIZED TOMOGRAPHY (CT) CHECK. ON (B)(6) 2024, THE PHYSICIAN CONDUCTED A PROCEDURE AND RETRIEVED THE VALVE AND CATHETER. PATIENT IS WAITING FOR THE REVISION PROCEDURE AFTER THE ANTI-INFECTION THERAPY. ACCORDING TO INFORMATION PROVIDED, THE TYPE OF INFECTION OR ORGANISM IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476718 CODMAN BACTISEAL CATHETER KIT BACTISEAL CATHETER KIT JXG INTEGRA LIFESCIENCES MANSFIELD 7281894 10381780515616

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Male HAKIM VALVE (ID 823114)