BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL Y-SITE CONNECTOR C80

    MDR report key: 9694513 · Received February 11, 2020

    Report

    Report Number
    3003152976-2020-00049
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905153045
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTOS, NO LEAKAGE CAN BE OBSERVED. FOUR RETAINED SAMPLES WERE EVALUATED, IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGES WERE OBSERVED. PRODUCT UNDERGOES BOTH VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1905101, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR C80 LEAKED FROM THE NOZZLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "LEAKAGE AT THE RINCE NOZZLE, IT'S RECURRING".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR C80 LEAKED FROM THE NOZZLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "LEAKAGE AT THE RINCE NOZZLE, IT'S RECURRING"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160511 BD PHASEAL Y-SITE CONNECTOR C80 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515304 1905101 30382905153045

    Patients

    Seq Age Sex Outcome Treatment
    1 Other