BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIALSOURCE TRANSRADIAL ACCESS KIT

    MDR report key: 3980210 · Received June 5, 2014

    Report

    Report Number
    2183787-2014-00078
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K110051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER FLUSHING THE RADIALSOURCE INTRODUCER, THE TIP OF THE DILATOR BROKE OFF. THE PHYSICIAN STILL USED THE CSI. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330472 RADIALSOURCE TRANSRADIAL ACCESS KIT TRANSRADIAL INTRODUCER DYB GREATBATCH MEDICAL 10913-007 W18499991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other