BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 12602687 · Received October 10, 2021

    Report

    Report Number
    3013886523-2021-00432
    Event Type
    Malfunction
    Date Received
    October 10, 2021
    Date of Event
    September 15, 2021
    Report Date
    April 19, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780515593
    PMA / PMN Number
    K102589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. THE CODMAN BACTISEAL EVD CATHETER (821745) WAS RETURNED FOR EVALUATION: REVIEW OF THE HISTORY DEVICE RECORDS FOR THE PRODUCT CODE 821745 WITH LOT 5510405 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS: THE CATHETER WAS VISUALLY INSPECTED; THE TIP WAS SLIGHTLY BENT. SOME RED/BROWN TRACES WERE NOTED ON THE CATHETER. REMARKS FROM THE PRODUCTION TEAM: IF THE GUIDE WIRE WAS NOT TO THE END OF THE CATHETER THIS WOULD NOT FIT IN THE BLISTER. THE MARKS ON CATHETER WOULD NOT BE ANTIBIOTICS AS ALL CATHETERS ARE CLEANED AND INSPECTED 100% TWICE. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS PROBABLY DUE TO HUMAN ERROR WRONG HANDLING, AS REPORTED BY THE TEAM: IF THE GUIDE WIRE WAS NOT TO THE END OF THE CATHETER THIS WOULD NOT FIT IN THE BLISTER. THE ROOT CAUSE FOR THE MARKS ON THE CATHETER NOTED DURING THE INVESTIGATION IS PROBABLY DUE TO HANDLING ON CUSTOMER SIDE.

    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

    A FACILITY REPORTED THE TIP OF THE CODMAN BACTISEAL EVD CATHETER WAS SIGNIFICANTLY BENT AND UNABLE TO USE. THERE WAS NO DAMAGE ON THE PACKAGE. THE PATIENT WAS PREPPED FOR SURGERY AND A FIVE-MINUTE DELAY WAS NOTED. THE DEVICE WAS NOT IN CONTACT WITH PATIENT AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500578 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 821745 5510405 10381780515593

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown