BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 15749730 · Received November 7, 2022

    Report

    Report Number
    3013886523-2022-00532
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    October 14, 2022
    Report Date
    December 7, 2022
    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 CATHETER (ID 821745) WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE). LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS DUE TO AN ISSUE WITH THE SILICONE COVER OR THE TROCAR. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. ADDITIONAL INFORMATION RECEIVED: INCIDENT DATE - (B)(6) 2022. DESCRIBE THE TYPE OF INJURY AND ITS SITE ¿ INJURY BROKE THE GLOVE BUT NOT SKIN. EXTENSION OF THE INJURY NOT SERIOUS, NO INJURY TO SKIN. WHAT STEPS WERE TAKEN FOR THE NURSE WHO RECEIVED THE INJURY AND WAS SHE OK FOLLOWING THE INCIDENT IMMEDIATE FIRST AID CARE ¿ WASH WOUND, NO FURTHER CARE REQUIRED. HOW IS THE SCRUB NURSE DOING? SCRUB NURSE IS OKAY. SHE IS UNDERGOING TESTING AS PER THE HOSPITALS PROTOCOL .

    Description of Event or Problem · 0

    A FACILITY REPORTED THE SILICON COVER OVER THE TROCAR OF A BACTISEAL CATHETER (ID 821745) WAS VERY DIFFICULT TO REMOVE CAUSING A SHARP INJURY TO A THEATRE SCRUB NURSE.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377344 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 821745 10381780515593

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown