BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ L CONNECTOR C90J

    MDR report key: 15415331 · Received September 13, 2022

    Report

    Report Number
    3003152976-2022-00416
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 19, 2022
    Report Date
    October 20, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES D10: RETURNED TO MANUFACTURER ON: 15OCT2022. H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. AFTER VISUAL INSPECTION, IT WAS OBSERVED THAT THE MEMBRANE WAS NEVER ASSEMBLED ONTO THE CONNECTOR BODY. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2201207, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED AND VERIFIED THE MEMBRANES WERE PROPERLY ASSEMBLED. ASSEMBLY OF THE MEMBRANE IS PERFORMED MANUALLY. A DETECTION SYSTEM IS USED TO VERIFY THE PROPER WELDING AND LOCATION OF THE MEMBRANE. ALL QUALITY RECORDS VERIFY THE INSPECTIONS WERE PERFORMED ACCORDING TO PROCEDURE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT IS DUE TO THE OPERATOR NOT PROPERLY WELDING THE MEMBRANE ONTO THE CONNECTOR BODY AND THE DETECTION SYSTEM ALSO NOT IDENTIFYING/REJECTING THE IMPACTED PIECE. A PROJECT WAS INITIATED TO FURTHER ADDRESS THIS ISSUE AND PREVENT ANY REOCCURRENCE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEMBRANE OF THE BD PHASEAL¿ L CONNECTOR C90J DETACHED AFTER PREPARING THE ANTICANCER AGENT, LEAKING TECENTRIQ AROUND IT AND ONTO THE HEALTHCARE PROFESSIONAL'S LEG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT DISCONNECTION OF THE MEMBRANE OF C90J, RESULTING IN CHEMO LEAKAGE. THE CUSTOMER REPORTED AS FOLLOWS: THE MEMBRANE OF L-CONNECTOR WAS DETACHED, WHICH RESULTED IN LEAKAGE OF THE ANTICANCER AGENT (TECENTRIQ). THIS OCCURRED AFTER PREPARATION, AND THE HCP WAS EXPOSED TO THE ANTICANCER AGENT ON HIS LEG."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEMBRANE OF THE BD PHASEAL¿ L CONNECTOR C90J DETACHED AFTER PREPARING THE ANTICANCER AGENT, LEAKING TECENTRIQ AROUND IT AND ONTO THE HEALTHCARE PROFESSIONAL'S LEG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT DISCONNECTION OF THE MEMBRANE OF C90J, RESULTING IN CHEMO LEAKAGE. THE CUSTOMER REPORTED AS FOLLOWS: THE MEMBRANE OF L-CONNECTOR WAS DETACHED, WHICH RESULTED IN LEAKAGE OF THE ANTICANCER AGENT (TECENTRIQ). THIS OCCURRED AFTER PREPARATION, AND THE HCP WAS EXPOSED TO THE ANTICANCER AGENT ON HIS LEG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364630 BD PHASEAL¿ L CONNECTOR C90J INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. 2201207

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown