BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 17741050 · Received September 13, 2023

    Report

    Report Number
    3013886523-2023-00315
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 16, 2023
    Report Date
    November 16, 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: (B)(6) ) WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    THE PERITONEAL CATHETER (ID 823045) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE CATHETER WAS IRRIGATED; NO OCCLUSIONS WERE NOTED. THE COMPLAINT WAS UNCONFIRMED. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE CATHETER AT THE TIME OF INVESTIGATION. HOWEVER, A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00314 A PHYSICIAN REPORTED A CERTAS VALVE (828804) WAS IMPLANTED VIA LUMBAR PERITONEAL (LP) SHUNT ON (B)(6) 2022 WITH SETTING 2. THE VALVE WAS USED WITH THE SILASCON® LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ), AND PERITONEAL CATHETER (823045) WITH UNKNOWN SERIAL NUMBER. ON (B)(6) 2022, THE PATIENT'S SYMPTOMS WORSENED. AN ENLARGEMENT OF THE VENTRICLES AND SUBCUTANEOUS CEREBROSPINAL FLUID RETENTION WERE CONFIRMED. THE PATIENT WAS DIAGNOSED WITH MENINGITIS. THE SETTING WAS CHANGED FROM 2 TO 1, HOWEVER THE PATIENT'S HYDROCEPHALUS DID NOT IMPROVE. ON (B)(6) 2023, THE SHUNT SYSTEM WAS REMOVED. WHEN THE CATHETER WAS REMOVED FROM THE ABDOMINAL CAVITY WITH THE VALVE AND LUMBAR CATHETER LEFT IN PLACE, THE RESERVOIR REMAINED DEPRESSED AND DID NOT RETURN DESPITE PUMPING. THERE WERE NO OBSTRUCTIONS OF THE LUMBAR CATHETER AND ABDOMINAL CATHETER. THE PATIENT IS CURRENTLY UNDER OBSERVATION WITH VENTRICULAR DRAINAGE. THE VALVE WAS REMOVED ON (B)(6) 2023 AND WAS NOT REPLACED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THERE IS AN OBSTRUCTION WITH THE VALVE. IT IS ALSO UNKNOWN IF THE INFECTION IS RELATED TO THE DEVICE OR IF ANYTHING HAPPENS DURING THE RECENT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO INFECTION.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615205 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780518839

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female CERTAS VALVE (828804)| SILASCON® LUMBAR CATHETER