BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HEX HANDLE SUMP SUCKER TIP

    MDR report key: 2969898 · Received February 15, 2013

    Report

    Report Number
    1625519-2013-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 14, 2013
    Manufacturer
    NOVOSCI CORP.
    Product Code
    DTS
    PMA / PMN Number
    K801400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR (NOVOSCI CORP.) IS UNCERTAIN IF THE SUSPECT MEDICAL DEVICE THAT MALFUNCTIONED WAS, IN FACT, MANUFACTURED BY THEM. ADDITIONALLY, ALL ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE USER (THE REPORT SOURCE) WERE UNSUCCESSFUL. THEREFORE, THE MFR (NOVOSCI CORP.) CANNOT IDENTIFY THE SUSPECT MEDICAL DEVICE LOT NUMBER, EXPIRATION DATE, DEVICE MFG DATE, NOR ANY INFO PERTAINING TO THE PT (OTHER THAN THAT THE PT IS "OK", ACCORDING TO THE USER - THE REPORT SOURCE). THE MFR (NOVOSCI CORP). ALSO ASKED THE USER (THE REPORT SOURCE) FOR EITHER (A) PHOTOGRAPHS OF THE SUSPECT MEDICAL DEVICE, OR (B) THE RETURN OF THE SUSPECT MEDICAL DEVICE ALONG WITH ANY OF ITS BROKEN PIECES. THE USER (THE REPORT SOURCE) WAS UNRESPONSIVE TO BOTH REQUESTS AND MENTIONED THAT THEY ARE "NOT FILING A COMPLAINT". DURING THE INITIAL 24 HOURS WHEN THE USER CONTACTED THE MFR (NOVOSCI CORP). TO INQUIRE ABOUT THE RADIOPACITY OF THE SUCKER TIP, NOVOSCI'S REGULATORY CONSULTANT WAS NOTIFIED, WHEREIN THE REGULATORY CONSULTANT CONCLUDED THAT THIS INQUIRY SHOULD NOT BE CONSIDERED A COMPLAINT. IN ADDITION, AN MDR DETERMINATION FORM WAS COMPLETED AND IT INDICATED THAT AN MDR FOR THIS INQUIRY WAS NOT REQUIRED. DURING A STAFF MEETING ON (B)(4) 2013, THE REGULATORY CONSULTANT REVISED THE EARLIER JUDGMENT REGARDING THE INQUIRY AND CONCLUDED THAT AN MDR SHOULD, IN FACT, BE INITIATED FOR THIS INQUIRY OF THE SUCKER TIP.

    Description of Event or Problem · 1

    USER CALLED MFR (NOVOSCI CORP.) AND INQUIRED ABOUT THE RADIOPACITY OF THE ADULT HEX HANDLE SUMP SUCKER TIP (P/N 201190-000) BECAUSE THE TIP HAD FALLEN OFF DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68646 ADULT HEX HANDLE SUMP SUCKER TIP NONE DTS NOVOSCI CORP. 201190-000

    Patients

    Seq Age Sex Outcome Treatment
    1