BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIPS DUAL 2 MINUTE TIP

    MDR report key: 3002688 · Received March 13, 2013

    Report

    Report Number
    0001811755-2013-00519
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED.

    Description of Event or Problem · 1

    UPON OPENING OF THE STERILE PACKAGING, FOREIGN MATERIAL WAS DISCOVERED TANGLED IN THE TUBING. THE STERILE FIELD WAS NOT COMPROMISED. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105661 SIPS DUAL 2 MINUTE TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-PUERTO RICO 31410011229712Q7

    Patients

    Seq Age Sex Outcome Treatment
    1