BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 15749015 · Received November 7, 2022

    Report

    Report Number
    3013886523-2022-00531
    Event Type
    Injury
    Date Received
    November 7, 2022
    Report Date
    February 3, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780515593
    PMA / PMN Number
    K102589
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    THE BACTISEAL EVD CATHETER (B)(4) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-1745 WITH LOT 6162832, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED, A CUT IN THE CATHETER WAS NOTED. THE LEAK WAS FROM TO THE HOLE; THE LEAK WAS CONFIRMED. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE CATHETER OR ATYPICAL HANDLING.

    Description of Event or Problem · 0

    A FACILITY REPORTED A BACTISEAL EVD CATHETER (ID: 821745) HAD A HOLE AT THE TIP END OF THE EVD, AND THERE WAS CSF LEAKAGE COMING FROM THE CATHETER CONNECTION. THE DAMAGED PART WAS CUT OFF AND RECONNECTED THE TUBING IN STERILE MANNER. EVD REMAINED IN SITU WITH NO FURTHER LEAK. NO PROCEDURAL DELAY.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377248 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 821745 6162832 10381780515593

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female