BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTISEAL PERITONEAL CATHETER

    MDR report key: 12125240 · Received July 6, 2021

    Report

    Report Number
    3013886523-2021-00288
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    June 16, 2021
    Report Date
    August 6, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K102589
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BACTISEAL CATHETER WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE (B)(4) WITH LOT 5183496 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; NO DEFECTS NOTED. NO OCCLUSIONS AND 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 BIOLOGICAL DEBRIS AND PROTEIN BUILDUP INTERFERING WITH THE CATHETER, AT THE TIME OF INVESTIGATION, NO OCCLUSION ISSUES WERE NOTED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    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 · 1

    3 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2021-00286. 3013886523-2021-00287. A FACILITY REPORTED A CODMAN HAKIM PROGRAMMABLE VALVE AND CATHETERS (823073 AND 823074) WERE IMPLANTED INTO A (B)(6) PATIENT ON (B)(6) 2021 WITH REMOVAL OF THE DEVICE OCCURRING 30 MINUTES LATER. THE PHYSICIAN FOUND THAT THERE WAS NO CEREBRAL SPINAL FLUID FLOWING OUT FROM THE ABDOMINAL CATHETER. THE PHYSICIAN DISCONNECTED THE ABDOMINAL CATHETER WITH THE VALVE AND THERE WAS NO CEREBRAL SPINAL FLUID FLOWING OUT FROM THE VALVE. DUE TO THE PATIENTS AGE, THE PHYSICIAN RETRIEVED THE HAKIM VALVE AND CATHETERS AND CHANGED WITH THE DEVICE OF ANOTHER COMPANY TO COMPLETE THE PROCEDURE AND LIMIT THE ANESTHESIA TIME. A 30-MINUTE SURGICAL DELAY WAS REPORTED DUE TO THE SHUNT ADVERSE EVENT. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022498 BACTISEAL PERITONEAL CATHETER BACTISEAL PERITONEAL CATHETER JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 5183496

    Patients

    Seq Age Sex Outcome Treatment
    1