BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 15464942 · Received September 22, 2022

    Report

    Report Number
    3013886523-2022-00438
    Event Type
    Injury
    Date Received
    September 22, 2022
    Date of Event
    August 19, 2022
    Report Date
    December 1, 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 (ID 823045) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETERS WERE IRRIGATED NO OCCLUSIONS NOTED. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE SMALL PIECES OF CATHETER RETURNED. THE POSSIBLE ROOT CAUSE COULD BE DUE TO VALVE AS THIS COMPLAINT IS IN CONNECTION WITH (B)(4).

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00437 A PHYSICIAN REPORTED A CERTAS VALVE (ID 8228814) WAS IMPLANTED DUE TO SNPH (SECONDARY NORMAL PRESSURE HYDROCEPHALUS) VIA VP SHUNT ON (B)(6) 2022 WITH SETTING 5. IT WAS USED WITH HAKIM PERITON CATH (ID 823045). ON (B)(6) 2022, PATIENT HYDROCEPHALUS WORSENED. THE SET PRESSURE OF THE VALVE COULD NOT BE CHANGED. A CEREBROSPINAL FLUID TEST SHOWED A HIGH PROTEIN CONCENTRATION OF 173 MG/DL. THE PHYSICIAN TRIED TO PASS WATER THROUGH THE PERITONEAL CATHETER DURING THE SURGERY AND THE FLOW WAS POOR. THEREFORE, THE VALVE AND THE PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661525 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3045 10886704041276

    Patients

    Seq Age Sex Outcome Treatment
    1 Female