BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE CATH PASSER 36CM

    MDR report key: 19780378 · Received July 19, 2024

    Report

    Report Number
    3014334038-2024-00154
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    June 6, 2024
    Report Date
    February 14, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K944222
    Adverse Event
    Yes
    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

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE DISPOSABLE CATHETER PASSER (ID 821515) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED HOWEVER, A POTENTIAL CAUSE OF THE REPORTED EVENT MAY BE RELATED TO EXCESS PRESSURE APPLICATION DURING THE PROCEDURE. 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.

    Description of Event or Problem · 0

    A FACILITY REPORTED A CATHETER PASSER (ID 821515) NICKED THE ANTERIOR JUGULAR VEIN WHILE TUNNELING DURING THE IMPLANT PROCEDURE. THE PHYSICIAN APPLIED PRESSURE TO STOP THE BLEEDING AND THIS RESOLVED THE ISSUE. ACCORDING TO INFORMATION PROVIDED, THERE IS NO SPECIFIED ISSUE WITH THE REPORTED PRODUCT. IT IS NOT SPECIFIED IF THERE WAS A SURGICAL DELAY IN THE PROCEDURE DUE TO A DEVICE ISSUE, OR IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499670 DISPOSABLE CATH PASSER 36CM SHUNT,NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other