BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR (P55)

    MDR report key: 10989090 · Received December 10, 2020

    Report

    Report Number
    3003152976-2020-00561
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    October 20, 2020
    Report Date
    January 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151171
    PMA / PMN Number
    K130197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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, A LEAKAGE WAS OBSERVED ON THE PROTECTOR MEMBRANE. THERE WAS NO VISIBLE DAMAGE OR OTHER DEFECTS ON THE MEMBRANE THAT COULD HAVE CONTRIBUTED TO THE LEAK OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2003127, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING MANUFACTURING, LEAKAGE TESTING IS PERFORMED, PENETRATING THE MEMBRANE TEN TIMES TO VERIFY IF ANY LEAKS OCCUR. TESTING WAS REVIEWED FOR LOT 2003127, ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE PROTECTOR ALONG WITH A SAMPLE INJECTOR TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS OCCURRED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOXORUBICIN LEAKED BETWEEN THE BD PHASEAL¿ PROTECTOR (P55) AND VIAL WHILE PREPARING IT FOR USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING PREPARATION OF DOXORUBICIN THE PHASEAL PROTECTOR P55 LEAKED AT THE PORT JUNCTION WITH THE PHASEAL INJECTOR AND IN THE SEALED EXPANSION CHAMBER.".

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # MW5097446. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOXORUBICIN LEAKED BETWEEN THE BD PHASEAL¿ PROTECTOR (P55) AND VIAL WHILE PREPARING IT FOR USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING PREPARATION OF DOXORUBICIN THE PHASEAL PROTECTOR P55 LEAKED AT THE PORT JUNCTION WITH THE PHASEAL INJECTOR AND IN THE SEALED EXPANSION CHAMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446966 BD PHASEAL PROTECTOR (P55) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515117 2003127 30382905151171

    Patients

    Seq Age Sex Outcome Treatment
    1