BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P55

    MDR report key: 16607633 · Received March 23, 2023

    Report

    Report Number
    9616066-2023-00544
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 9, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    ONB
    UDI-DI
    30382905151171
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 09-MAR-2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, NO DEFECTS OR ISSUES OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, LIQUID INSIDE THE SYRINGE COULD MOVE TO THE VIAL AND BACK TO THE SYRINGE WITHOUT ISSUE AND NO LEAKS WERE OBSERVED. LEAKAGE TESTING IS PERFORMED FOR ALL LOTS DURING MANUFACTURING TO ENSURE THE QUALITY OF THE MEMBRANE. FURTHER TESTING WAS CONDUCTED AND AFTER PROPERLY RECONNECTING THE VIAL AND PROTECTOR, NO SIGN OF LEAKAGE OCCURRED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201141 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. PRODUCT UNDERGOES A SERIES OF TESTING DURING MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE PROTECTOR WAS NOT PROPERLY CONNECTED TO THE VIAL WHICH RESULTED IN THE LEAK REPORTED. THE PROTECTOR MUST BE ATTACHED COMPLETELY VERTICAL TO THE VIAL.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ PROTECTOR P55 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT CHEMO LEAKAGE WITH THE USE OF PROTECTOR. ACCORDING TO THE CUSTOMER'S REPORT, AFTER ATTACHING THE PROTECTOR TO THE VIAL OF ENDOXAN, LEAKAGE WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ PROTECTOR P55 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT CHEMO LEAKAGE WITH THE USE OF PROTECTOR. ACCORDING TO THE CUSTOMER'S REPORT, AFTER ATTACHING THE PROTECTOR TO THE VIAL OF ENDOXAN, LEAKAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372460 BD PHASEAL¿ PROTECTOR P55 INTRAVASCULAR ADMINISTRATION SET ONB SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 515117 2201141 30382905151171

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown