BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 21432802 · Received February 21, 2025

    Report

    Report Number
    3013886523-2025-00040
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    January 29, 2025
    Report Date
    April 30, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518839
    PMA / PMN Number
    K944222
    Adverse Event
    Yes
    Product Problem
    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE PERITONEAL CATHETER (ID 823045) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; NO DEFECTS NOTED. THE CATHETER WAS LEAK TESTED; A LEAK WAS OBSERVED. THE CATHETER WAS IRRIGATED, NO OCCLUSIONS NOTED. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE ANALYSIS - THE ISSUE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE POSSIBLE ROOT CAUSE COULD BE A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE DEVICE OR THE STAPLER HAVING DAMAGED THE CATHETER. AS NOTED IN THE IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A PERITONEAL CATHETER (ID 823045) WAS IMPLANTED ON (B)(6) 2025. A LEAK WAS OBSERVED FROM THE CATHETER THREE DAYS AFTER IMPLANTATION. A RE-OPERATION WAS PERFORMED; ONLY THE PART THAT WAS LEAKED WAS CUT AND A CONNECTOR WAS USED TO FIX IT. THE DOCTOR ASSUMED THAT THE STAPLER MAY HAVE DAMAGED THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634445 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780518839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention