BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL CATHETER KIT

    MDR report key: 10280905 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00299
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    May 21, 2020
    Report Date
    May 22, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K102589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFICATION (UDI): (B)(4). THE CODMAN BACTISEAL CATHETER KIT WAS NOT RETURNED FOR EVALUATION THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER:1226348-2020-00300. A FACILITY REPORTED INTRACRANIAL INFECTION: THE PATIENT WAS IMPLANTED WITH 823114 (MICRO CHPV UNITIZED) AND 823072 (BACTISEAL CATHETER KIT) ON (B)(6) 2020, A WEEK LATER THE PATIENT WAS FOUND WITH INTRACRANIAL INFECTION, POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. ON (B)(6) 2020, THE PHYSICIAN CONDUCTED A REVISION PROCEDURE TO RETRIEVE THE VALVE AND CATHETER. THE PATIENT WAS PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738552 CODMAN BACTISEAL CATHETER KIT BACTISEAL CATHETER KIT JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 3984387

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR