BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 16241584 · Received January 25, 2023

    Report

    Report Number
    3013886523-2023-00014
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    January 13, 2023
    Report Date
    May 10, 2023
    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

    THE HAKIM PERITONEAL CATHETER (ID 823045) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS- THE CATHETER IS TO SHORT FOR ANY INVESTIGATION. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT DO ANY TEST WITH THE SHORT CATHETER AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE CATHETER OR COULD BE DUE A KINK IN THE CATHETER.

    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

    N/A.

    Description of Event or Problem · 0

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00013. A PHYSICIAN REPORTED A CERTAS VALVE (ID (B)(6) WAS IMPLANTED DUE TO SAH (SUBARACHNOID HEMORRHAGE) VIA L-P SHUNT ON (B)(6) 2022 WITH UNKNOWN SETTING. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ) AND 823045 (HAKIM PERITONEAL CATHETER. SINCE THE HYDROCEPHALUS GOT WORSE, THE SET PRESSURE OF THE VALVE WAS LOWERED TO 3 ON UNKNOWN DATE. A PATENCY CHECK SHOWED THAT THE VALVE RESPONSE WAS SLOW, SO WHEN THE CONTRAST MEDIUM WAS FLOWED, IT FLOWED ONLY IN THE DIRECTION OF THE LUMBAR CATHETER. OBSTRUCTION WAS SUSPECTED, THEREFORE, THE VALVE WAS REMOVED ON (B)(6) 2023. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED SIGNS AND SYMPTOMS OF VALVE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315963 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3045 10886704041276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown