BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ L CONNECTOR C90J

    MDR report key: 8791733 · Received July 15, 2019

    Report

    Report Number
    3003152976-2019-00464
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 27, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND A LEAKAGE WAS OBSERVED BETWEEN THE RUBBER STOPPER OF THE INFUSION BAG AND THE L-CONNECTOR. IT WAS NOTED THE SPIKE ON THE CONNECTOR WAS NOT FULLY ATTACHED TO THE INFUSION BAG AND THERE WAS A LARGE CRACK ON THE RUBBER STOPPER OF THE INFUSION BAG WHERE THE PRODUCT CONNECTS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1811108 AND 1811102, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES A SERIES OF TESTS AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING. LOT RELEASE TEST RESULTS WERE REVIEWED FOR THE REPORTED LOTS AND NO ISSUES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINED A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND A LEAKAGE WAS OBSERVED BETWEEN THE RUBBER STOPPER OF THE INFUSION BAG AND THE L-CONNECTOR. IT WAS NOTED THE SPIKE ON THE CONNECTOR WAS NOT FULLY ATTACHED TO THE INFUSION BAG AND THERE WAS A LARGE CRACK ON THE RUBBER STOPPER OF THE INFUSION BAG WHERE THE PRODUCT CONNECTS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1811108 AND 1811102, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES A SERIES OF TESTS AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING. LOT RELEASE TEST RESULTS WERE REVIEWED FOR THE REPORTED LOTS AND NO ISSUES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINED A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ L CONNECTOR C90J THERE WAS LEAKAGE AT THE L CONNECTOR AND THE INFUSION SET. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: CONNECTED INFUSION BAG TO L CONNECTOR AND HCP PREPARED 5FU(CHEMO) THEN CONNECTED INFUSION SET. LEAKAGE OCCURRED FROM THE CONNECTION OF L CONNECTOR AND INFUSION SET.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ L CONNECTOR C90J THERE WAS LEAKAGE AT THE L CONNECTOR AND THE INFUSION SET. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CONNECTED INFUSION BAG TO L CONNECTOR AND HCP PREPARED 5FU(CHEMO) THEN CONNECTED INFUSION SET. LEAKAGE OCCURRED FROM THE CONNECTION OF L CONNECTOR AND INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583969 BD PHASEAL¿ L CONNECTOR C90J INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other