BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 23154495 · Received September 26, 2025

    Report

    Report Number
    3013886523-2025-00251
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 26, 2025
    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

    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM PERITONEAL CATHETER (ID 823045) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 823045 WITH LOT 7344361, SN UNKNOWN, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; NO DEFECTS NOTED. THE CATHETER WAS LEAK TESTED, NO LEAK WAS OBSERVED. THE CATHETER WAS IRRIGATED, NO OCCLUSIONS WAS NOTED. THE COMPLAINT WAS NOT CONFIRMED. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED. AS NOTED IN THE INVESTIGATION, NO LEAKAGE WAS NOTED WITH THE RETURNED 730MM CATHETER. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CLEARLY DETERMINED AS ONLY 730MM CATHETER OF THE 1200MM WERE RETURNED. THE ISSUE COULD BE LINKED TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE DEVICE. AS NOTED IN THE IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTED A HAKIM PERITONEAL CATHETER (ID (B)(6)) WAS IMPLANTED DUE TO NONCOMMUNICATING HYDROCEPHALUS VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE. THE CATHETER WAS LEAKING, THEREFORE IT WAS REMOVED AND REPLACED ON (B)(6) 2025. NO DAMAGE WAS OBSERVED WITH VISUAL INSPECTION. ACCORDING TO INFORMATION PROVIDED, THE ESTIMATED AMOUNT OF CEREBROSPINAL FLUID (CSF) LEAKAGE IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO PRODUCT PROBLEM.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315911 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7344361 10381780518839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention