BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED Q-SYTE¿ DEVICE

    MDR report key: 6894349 · Received September 26, 2017

    Report

    Report Number
    9610847-2017-00091
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 14, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. FDA NOTIFIED: YES THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # 5071638. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT WHILE SHE WAS INFUSING REMODULIN USING AN UNSPECIFIED Q-SYTE¿ DEVICE HER LINE STARTED LEAKING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675850 UNSPECIFIED Q-SYTE¿ DEVICE Q-SYTE SPLIT SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other