BEUDAMED
    FDA Adverse Event Other Summary report: N

    SL V-CATH PICC MINI

    MDR report key: 2753784 · Received September 13, 2012

    Report

    Report Number
    2925153-2012-00007
    Event Type
    Other
    Date Received
    September 13, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 13, 2012
    Manufacturer
    NEO MEDICAL, INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION (B)(4). THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR BASED ON OUR MDR REPORTING CRITERIA. THE COMPLAINANT STATES "NO DEVICE IS AVAILABLE FOR EVALUATION FOR LOT# 1105". DEVICE HISTORY REVIEW: TOTAL OF 596 UNITS WERE MADE IN LOT 1105. ALL FINISHED DEVICES PASSED IN-PROCESS, FINAL , AND POST-STERILIZATION INSPECTION. THERE HAVE BEEN NO OTHER COMPLAINTS FOR (B)(4) LOT #1105. AN EXAMINATION OF THE DEVICE CAN NOT BE CARRIED AS THE USED DEVICE WAS NOT RETURNED TO NEO MEDICAL. CAUSE IS UNDETERMINED, COMPLAINANT STATES "IT IS UNKNOWN IF THE DEVICE ISSUE, WAS CAUSED BY THE END USER". THIS IS THE SECOND COMPLAINT "LINE LEAKED" FROM THE SAME END USER (B)(6) IN A 30 DAY PERIOD.

    Description of Event or Problem · 1

    LINE WAS FOUND TO HAVE EITHER A CRACK IN THE LINE, OR A HOLE IN THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL V-CATH PICC MINI 2FR SL V-CATH PICC DQY NEO MEDICAL, INC 355-72 1105

    Patients

    Seq Age Sex Outcome Treatment
    1