BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 20150637 · Received September 5, 2024

    Report

    Report Number
    3013886523-2024-00267
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    July 19, 2024
    Report Date
    February 27, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K944222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: D4 - CUSTOMER INITIALLY PROVIDED LOT 7270783, HOWEVER, CUSTOMER CONFIRMED LATER THE LOT NUMBER IS UNKNOWN. THE HAKIM PERITONEAL CATHETER (ID 823045) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; NO DEFECTS NOTED. THE CATHETER WAS IRRIGATED, NO OCCLUSIONS NOTED. THE VALVE WAS LEAK TESTED; NO LEAKS WERE NOTED. THE COMPLAINT WAS UNCONFIRMED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. THE 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.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2024-00266 A PHYSICIAN REPORTED A VENTRICULAR CATHETER (ID 823041) AND A PERITONEAL CATHETER (ID 823045) WERE IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE CATHETERS WERE USED TOGETHER WITH A CERTAS PLUS VALVE (ID 828804). ALL THREE DEVICES WERE REMOVED ON AN UNKNOWN DATE DUE TO THE VALVE NOT FUNCTIONING PROPERLY AFTER IMPLANTATION. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THERE WAS AN ISSUE WITH THE CATHETERS, HOWEVER, THEY WERE EXPLANTED. IT IS ALSO UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS OR SYMPTOMS DUE TO VALVE FAILURE. THE PATIENT'S CONDITION IS UNKNOWN.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074756 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7270783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CERTAS VALVE (ID 828804)| VENTRICULAR CATHETER (ID 823041)