BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 18192182 · Received November 22, 2023

    Report

    Report Number
    3013886523-2023-00392
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    October 18, 2023
    Report Date
    January 19, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518839
    PMA / PMN Number
    K944222
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823045) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE CATHETER WAS IRRIGATED, NO OCCLUSIONS WERE NOTED. THE VALVE WAS LEAK TESTED; LEAKS WERE NOTED. ROOT CAUSE ANALYSIS ¿ NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE CATHETER AT THE TIME OF INVESTIGATION. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE CATHETER. AT THE TIME OF INVESTIGATION, NO FUNCTION ISSUES WERE NOTED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM PERITONEAL CATHETER (ID 823045) AND A CONNECTOR (ID 823053) WERE IMPLANTED IN A 42 YEAR-OLD MALE PATIENT VIA VENTRICULOPERITONEAL SHUNT ON (B)(6) 2023. THE CATHETER WAS CONNECTED TO A COMPETITOR¿S VALVE WHICH WAS ALREADY IMPLANTED. ON (B)(6), 2023, OVERDRAINAGE WAS OBSERVED. A SHUNT CONTRAST WAS PERFORMED AND CEREBROSPINAL FLUID (CSF) LEAKAGE FROM THE CATHETER WAS FOUND. ON (B)(6) 2023, THE CATHETER WAS EXPLANTED AND REPLACED, CONNECTOR REMAINED IMPLANTED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO OVERDRAINAGE AND CSF LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744892 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780518839

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male SHUNT CONNECTOR (ID 823053)