BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTISEAL PERITONEAL CATHETER

    MDR report key: 14021990 · Received April 6, 2022

    Report

    Report Number
    3013886523-2022-00140
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 2, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041337
    PMA / PMN Number
    K102589
    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, H10 THE PERITONEAL CATHETER (ID 823074) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETERS WERE VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE CATHETER WAS IRRIGATED NO OCCLUSIONS NOTED. THE CATHETER WAS LEAK TESTED NO LEAKS NOTED. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE CATHETER AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS INTERFERING WITH THE DEVICE, AT THE TIME OF INVESTIGATION NO FUNCTIONAL ISSUES WERE NOTED.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00139 . A PHYSICIAN REPORTED A CERTAS VALVE WAS IMPLANTED IN A (B)(6) FEMALE PATIENT DUE TO SAH (SUBARACHNOID HEMORRHAGE) VIA L-P SHUNT ON (B)(6) 2022 WITH SETTING 3. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ) AND BACTISEAL PERITONEAL CATHETER (ID 823074-SERIAL;UNK). ON MARCH 11, THE PATIENT HAD DISORIENTATION. THE PRESSURE SETTING WAS CHANGED WITH ETK FOR FLUOROSCOPY (3 TO 2). ON MARCH, 17, THE PATIENT HAD DISORIENTATION. A SHUNT CONTRAST WAS PERFORMED, BUT NO OBSTRUCTION WAS OBSERVED. ON MARCH 18, NO IMPROVEMENT IN SYMPTOMS WAS SEEN, THE VALVE AND PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2022.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580341 BACTISEAL PERITONEAL CATHETER BACTISEAL PERITONEAL CATHETER JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3074 10886704041337

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female