BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOMEDICAL POWER-V PICC

    MDR report key: 1671504 · Received April 27, 2010

    Report

    Report Number
    2925153-2010-00004
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    January 16, 2010
    Report Date
    April 12, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREVIOUSLY ASSESSED AND THE DECISION WAS THERE WAS NO INDICATION FOR MDR REPORTING, BASED ON THE EXISTING MDR REPORTING CRITERIA. THIS COMPLAINT FILE WAS REVIEWED BY THREE FDA INSPECTORS AND THE CONTENTS DID NOT WARRANT A MDR REPORT FILING. (B)(4) HAS UPDATED ITS COMPLAINT HANDLING AND MDR REPORTING PROCEDURES. THE 2009 AND 2010 COMPLAINT FILES WERE RE-EXAMINED AND BASED ON THE CHANGED CRITERIA THIS MDR REPORT IS BEING FILED. AN EXAMINATION OF THE DEVICE WAS CARRIED OUT AS PART OF THE COMPLAINT INVESTIGATION. THE CONCLUSION IN SUMMARY WAS THAT THE INSTRUCTIONS FOR USE, PACKAGED WITH THE PRODUCT WAS INCORRECTLY FOLLOWED BY USER.

    Description of Event or Problem · 1

    BASED ON THE REPORT INFORMATION, SUBMITTED TO (B)(4) ON (B)(6) 2010, "GUIDEWIRES COULD NOT BE PULLED OUT OF CATHETER DURING FINAL STEP OF PICC PLACEMENT. DISTAL END SEEMED TO GET STUCK IN CATHETER AT 48 CM WITH NOTICEABLE BULGE. PICC HAD TO BE REMOVED AND PLACEMENT PROCESS STARTED AGAIN WITH ANOTHER PICC OF THE SAME KIND. TWO REPORTS. AN UNOPENED SAMPLE WAS RETURNED FOR COMPARATIVE EXAMINATION. THE PRODUCT SAMPLES WERE RETURNED FOR EXAMINATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMEDICAL POWER-V PICC NEOMEDICAL POWER-V PICC DQY NEOMEDICAL 5078-2660 1002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention