BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPULSE

    MDR report key: 5008645 · Received August 13, 2015

    Report

    Report Number
    1000304305-2015-00001
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    January 1, 2015
    Report Date
    July 20, 2015
    Manufacturer
    NP MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K130023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ALTHOUGH REQUESTED, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THIS EVENT OCCURRED OUTSIDE OF THE US AND INVOLVES A DEVICE THAT IS SIMILAR TO ONE THAT IS CLEARED FOR USE DOMESTICALLY. (REFERENCE 510K NUMBER). THE CUSTOMER REPORTED A LEAKAGE COMPLAINT FROM AN ONCOLOGY DEPARTMENT. THE PATIENT WAS TREATED WITH AN ANTINEOPLASTIC DRUG. THE NPULSE VALVE WAS CONNECTED TO A PERIPHERALLY INSERTED CENTRAL CATHETER (BARD PICC PART NUMBER 7712300). LEAKAGE OF INFUSION FLUID WAS OBSERVED AT THE CONNECTION SITE. TO DATE, THE ROOT CAUSE OF THE LEAKAGE COULD NOT SOLELY BE ATTRIBUTED TO THE NPULSE VALVE. THERE WAS NO REPORT OF PATIENT/CLINICIAN INJURY NOR WAS MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE HAS YET BEEN PROVIDED. AS PART OF THE COMPLAINT INVESTIGATION, COMPATIBILITY TESTING WAS COMPLETED BETWEEN THE NPULSE VALVE AND THE BARD PICC PART NUMBER 7712300. UTILIZING THESE DEVICES IN A LAB SETTING, LEAKAGE WAS NOT CONFIRMED IN A PRESSURIZED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532774 NPULSE NEEDLE FREE ACCESS DEVICE FPA NP MEDICAL, INC. K100-SSG4G5SA NP34514AD

    Patients

    Seq Age Sex Outcome Treatment
    1