BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 14159924 · Received April 20, 2022

    Report

    Report Number
    3013886523-2022-00172
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 22, 2022
    Report Date
    June 9, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041276
    PMA / PMN Number
    K944222
    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

    THE HAKIM PERITONEAL CATHETER WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETERS WERE VISUALLY INSPECTED; NO DEFECTS WERE NOTED. ALL ENDS FOR THE CATHETERS SEEM TO BE CLEAN CUT. THE CATHETERS WERE IRRIGATED NO OCCLUSIONS NOTED. THE CATHETERS WERE LEAK TESTED NO LEAKS NOTED. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE CATHETERS AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO USER¿S ERROR, POSSIBLE WHEN CONNECTING THE CATHETERS, AT THE TIME OF INVESTIGATION, NO OCCLUSION ISSUES WERE NOTED WITH THE CATHETERS.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00171. SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS. THE PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED IN A (B)(6) FEMALE PATIENT VIA "L-P SHUNT" ON (B)(6) 2021 WITH SETTING 5. THE VALVE WAS USED WITH A 823045 (SERIAL: UNK) AND THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). ON (B)(6) 2021 THE PATIENT COMPLAINED OF HEADACHE, THE SET PRESSURE OF THE VALVE WAS CHANGED TO SETTING 7 AND SYMPTOM IMPROVED. ON (B)(6) 2022 , THE PATIENT HAD A GAIT DISORDER AND SET PRESSURE WAS CHANGED TO SETTING 2. THE PATIENT'S SYMPTOMS DID NOT IMPROVE AND VENTRICULAR ENLARGEMENT WAS OBSERVED. THE VALVE, PERITONEAL CATHETER (823045) AND THE SILASCON LUMBAR CATHETER WERE REMOVED ON (B)(6) 2022. A RUPTURE OF THE LUMBAR CATHETER WAS CONFIRMED AT THE TIME OF REMOVAL. THE VALVE WAS REPLACED VIA "V-P SHUNT" ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2749568 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3045 10886704041276

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female