BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT

    MDR report key: 1205708 · Received October 10, 2008

    Report

    Report Number
    1217052-2008-00099
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATIONS: OUR INVESTIGATION INTO THIS EVENT IS BASED ON THE DIGITAL PHOTOS SUPPLIED BY SMITHS MEDICAL. THE SAMPLE DEFORMITY APPEARS TO BE CONSISTENT WITH MECHANICAL DAMAGE CAUSED BY THE SYRINGE BARREL COMING INTO CONTACT WITH ANOTHER RIDGED OBJECT DURING ASSEMBLY. PREVIOUSLY, THERE WAS A DRYER MISALIGNMENT THAT WAS IDENTIFIED AND CORRECTED PRIOR TO THE RECEIPT OF THIS COMPLAINT. IT IS HYPOTHESIZED THIS DRYER MISALIGNMENT WOULD CAUSE THIS TYPE OF DEFECT. THE MFG RECORDS, OF THE TWO POSSIBLE LOTS, WERE REVIEWED, AND FOUND TO HAVE NO NOTATION REGARDING THIS ISSUE. MANUFACTURING HAS BEEN NOTIFIED OF THE ISSUE, AND HAS A HEIGHTENED AWARENESS OF THIS TYPE OF DEFECT. A REVIEW OF OUR COMPLAINTS DATABASE REVEALS NO OTHER REPORTS ON THE TWO POSSIBLE DEVICE LOT NUMBERS GIVEN. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    USER REPORTS BLOOD LEAKED FROM THE SYRINGE TIP AND DROPLETS ENTERED THE DOCTOR'S EYE. IT IS UNKNOWN IF THE UNIT WAS EXAMINED BEFORE USE. NO TREATMENT GIVEN THAT WE HAVE BEEN NOTIFIED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT 75 GJE - TRAY, BLOOD COLLECTION GJE SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1