BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.0 FR W/-4 VITACUFF PERC

    MDR report key: 8113201 · Received November 28, 2018

    Report

    Report Number
    3006260740-2018-03426
    Event Type
    Injury
    Date Received
    November 28, 2018
    Report Date
    November 28, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036767
    PMA / PMN Number
    K831386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUFF ALLEGEDLY DETACHED COMPLETELY OFF THE CHRONIC CATHETER DURING INSERTION. IT WAS FURTHER REPORTED THAT THE DETACHED CUFF HAD TO BE RETRIEVED. THE PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950509 8.0 FR W/-4 VITACUFF PERC CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 7711804 RECU2174 00801741036767

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention