BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ Y-SITE CONNECTOR (C80)

    MDR report key: 17477324 · Received August 7, 2023

    Report

    Report Number
    3002682307-2023-00228
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 21, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905153044
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE PROVIDED TO OUR QUALITY FOR EVALUATION. THROUGH VISUAL INSPECTION, THE MATERIAL INFORMATION IS DISPLAYED, HOWEVER, THERE IS NO EVIDENCE OF A LEAK OR DAMAGE TO THE DEVICE THAT COULD CONTRIBUTE TO THE LEAK REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2202228, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. NO ISSUES RELATED TO THE REPORTED EVENT WERE FOUND DURING MANUFACTURING. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO DAMAGE WAS OBSERVED AND NO LEAKAGES OCCURRED. BASED ON THE QUALITY TEAM'S INVESTIGATION, AND GIVEN THE RETAINED SAMPLES AND DEVICE RECORDS DID NOT IDENTIFY ANY ISSUES RELATED TO THIS INCIDENT, A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR (C80) WAS LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITITAL REPORTER: VERBATIM: CLINICIANS HAVE REPORTED THAT THE Y-SITE CONNECTOR ARE LEAKING - SEVERAL REPORTS MADE. THIS PRODUCT IS USED FOR BCG TREATMENT AND NEEDS TO BE A CLOSED SYSTEM. THE LEAKING IS NOTED AT THE BOTTOM (MALE LEUR-LOCK END) THAT ATTACHES CLOSEST TO THE CATHETER PHOTOS SUPPLIED AS THE ITEM WAS DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ Y-SITE CONNECTOR (C80) WAS LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITITAL REPORTER: VERBATIM: CLINICIANS HAVE REPORTED THAT THE Y-SITE CONNECTOR ARE LEAKING- SEVERAL REPORTS MADE. THIS PRODUCT IS USED FOR BCG TREATMENT AND NEEDS TO BE A CLOSED SYSTEM. THE LEAKING IS NOTED AT THE BOTTOM (MALE LEUR-LOCK END) THAT ATTACHES CLOSEST TO THE CATHETER PHOTOS SUPPLIED AS THE ITEM WAS DISCARDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459312 BD PHASEAL¿ Y-SITE CONNECTOR (C80) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2202228 00382905153044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown