BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 17729557 · Received September 12, 2023

    Report

    Report Number
    3013886523-2023-00306
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    August 23, 2023
    Report Date
    December 11, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518839
    PMA / PMN Number
    K944222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM PERITONEAL CATHETER (ID 823045) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETERS WERE VISUALLY INSPECTED; NO DEFECTS WERE FOUND. THE CATHETERS WERE IRRIGATED, NO OCCLUSIONS NOTED. THE COMPLAINT IS UNCONFIRMED. ROOT CAUSE ANALYSIS - NO ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DETERMINED AS NO DEFECTS COULD BE FOUND WITH THE CATHETERS. HOWEVER, A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO CATHETER SUSCEPTIBLE TO KINKING WHICH COULD LEAD TO AN OCCLUSION.

    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.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00305. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) AND A HAKIM PERITONEAL CATHETER (ID 823045) WERE IMPLANTED VIA LUMBAR PERITONEAL SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. ON (B)(6) 2023, GAIT DISORDER WAS OBSERVED AND OBSTRUCTION WAS SUSPECTED. THE VALVE AND HAKIM CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2023. THE PATIENT RECOVERED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE HAKIM CATHETER FAILED, HOWEVER IT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231448 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780518839

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SILASCON LUMBAR CATHETER (MANUF BY KANEKA:702-JJ)