BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT

    MDR report key: 3890676 · Received June 2, 2014

    Report

    Report Number
    3006260740-2014-00279
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    PMA / PMN Number
    K090101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REXL1125 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (REXL1125) HAVE BEEN REPORTED FROM ONE U.S. FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN AIR EMBOLISM THAT WAS SEEN ON POST-OP ON THE AIRGUARD. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321859 OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT MSD BARD ACCESS SYSTEMS REXL1125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention