BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWER-V PICC 5 FR DUAL LUMEN

    MDR report key: 1671507 · Received April 27, 2010

    Report

    Report Number
    2925153-2009-00009
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    October 21, 2009
    Report Date
    April 9, 2010
    Manufacturer
    NEOMEDICAL, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. NEOMEDICAL 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 INVESTIGATION OF THIS REPORT. THE CONCLUSION OF THE INVESTIGATION WAS THAT THE CATHETER WAS OVER-PRESSURIZED. THE OVER-PRESSURIZATION WAS PROBABLY CAUSED BY THE USER OBSERVED KINK.

    Description of Event or Problem · 1

    THE REPORT RECEIVED ON (B)(6) 2009 STATED IN SUMMARY: ON (B)(6) 2009, THE PICC WAS INSERTED. WITH THE DEVICE IN SITE, THE PHYSICIAN REALIZED PROBLEMS DURING INFUSION AND SUCTION; DURING INFUSION HE REALIZED A RETURN OF THE INFUSED SOLUTION (SALINE SOLUTION 0.9% WITH DISPOSABLE 10 ML SYRINGE, FLASHING FLOW) SO HE DECIDED TO REMOVE THE DEVICE. INTERVENTION IN THE FORM OF FLUOROSCOPY WAS USED. THE PATIENT IS GOOD. THE PRODUCT SAMPLE WAS RETAINED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER-V PICC 5 FR DUAL LUMEN V-CATH LJS NEOMEDICAL, INC. 5025-2660 1004 A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention