BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH PICC

    MDR report key: 1781413 · Received July 28, 2010

    Report

    Report Number
    2925153-2010-00012
    Event Type
    Other
    Date Received
    July 28, 2010
    Report Date
    July 26, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ASSESSED AND DETERMINED TO BE A MDR REPORT BASED ON OUR MDR REPORTING CRITERIA. THE INFO PROVIDED WITH THE INITIAL REPORT ON (B)(4) 2010 AND ALSO IN THE FOLLOW UP, ON (B)(4) 2010, SUGGESTS THAT THE ISSUES ENCOUNTERED MAY BE RELATED TO THE USER. THIS REPORT WILL BE INVESTIGATED SO AS TO ESTABLISH THE ACTUAL CAUSE. AN EXAMINATION OF THE DEVICE(S) HAS NOT BEEN CARRIED OUT AS THE USED ITEM(S) ARE TO BE STERILIZED BEFORE HANDLING BY THE INVESTIGATOR.

    Description of Event or Problem · 1

    BASED ON THE REPORT INFO, SUBMITTED TO NEOMEDICAL, PICC LINE NURSE WAS PLACING 3.0 FRENCH V-CATH PICC LINES LOT # 1002 ON A PT. AS SHE WAS PLACING THE LINE AND REMOVING THE WIRE, SHE BELIEVES THE WIRE POSSIBLY SHEARED THE CATHETER. SHE WENT TO FLUSH AND IT WAS LEAKING. THERE WERE TWO HOLES NOTED ON EACH SIDE OF THE HUB. SHE DILATED BACK UP AND INSERTED A 2ND 3.0 FRENCH V-CATH PICC LINE WITH THE SAME LOT # 1002. THE SAME THING HAPPENED. THE THIRD TIME SHE DILATED UP AND USED A 3.9 DUAL LUMEN OICC AND HAD NO PROBLEMS OR COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC 3 FR PICC DQY NEOMEDICAL 3081-1660 1002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention