BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULLET-TIP AORTIC PUNCH

    MDR report key: 2934834 · Received January 23, 2013

    Report

    Report Number
    1649914-2013-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT THE PHYSICIAN EXPERIENCED A DEVICE MALFUNCTION INVOLVING THE AORTIC PUNCH. THE PUNCH ALLEGEDLY BECAME STUCK DURING USE. ADDITIONAL INFO REGARDING THE ALLEGED EVENT WAS REQUESTED. THE NURSE MANAGER REPLIED THERE WERE NO INTERVENTION MEASURES REQUIRED BY THE PHYSICIAN AND THERE WERE NO PT COMPLICATIONS AS A RESULT OF THE REPORTED MALFUNCTION. THE PUNCH WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33192 BULLET-TIP AORTIC PUNCH BULLET PUNCH DWS QUEST MEDICAL, INC. RCB40 0408021C08

    Patients

    Seq Age Sex Outcome Treatment
    1