BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR SOLUS P120J

    MDR report key: 9812192 · Received March 10, 2020

    Report

    Report Number
    3003152976-2020-00110
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 1, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-02-28. H.6. INVESTIGATION SUMMARY ONE PROTECTOR CONNECTED TO A VIAL WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS EVALUATED AND NO DAMAGE OR DEFECTS WERE OBSERVED ON THE PROTECTOR OR PROTECTOR MEMBRANE. THE PROTECTOR WAS PROPERLY FITTED TO THE VIAL AND THE NEEDLE OF THE PROTECTOR PROPERLY PENETRATED THE VIAL STOPPER, HOWEVER, THE VIAL WAS OBSERVED TO BE BROKEN. FUNCTIONAL TESTING WAS PERFORMED, LIQUID COULD MOVE BETWEEN THE SYRINGE AND VIAL WITHOUT ISSUE. LEAKAGE TESTING IS PERFORMED FOR ALL LOTS DURING MANUFACTURING TO ENSURE THE QUALITY OF THE MEMBRANE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1910123 AND 1912116, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ALL TESTING RESULTS WERE REVIEWED FOR BOTH LOTS AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, WE ARE NOT ABLE TO IDENTIFY A ROT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROTECTOR SOLUS P120J LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE OCCURRED WHEN PREPARING RITUXIMAB. CONNECED P120J TO THE VIAL. CONNECTED N35C TO THE SYRINGE WHICH FILLED WITH AIR. CONNECED P120J AND N35C, INJECTED AIR FROM THE SYRINGE TO THE VIAL. DRUG LEAKED WHEN DRAWING IT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 1910123, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2019-11-22. MEDICAL DEVICE LOT #: 1912116, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: 2019-12-17. 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 · 1

    IT WAS REPORTED THAT PROTECTOR SOLUS P120J LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE OCCURRED WHEN PREPARING RITUXIMAB. CONNECTED P120J TO THE VIAL. CONNECTED N35C TO THE SYRINGE WHICH FILLED WITH AIR. CONNECTED P120J AND N35C, INJECTED AIR FROM THE SYRINGE TO THE VIAL. DRUG LEAKED WHEN DRAWING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278280 PROTECTOR SOLUS P120J PROTECTOR ONB BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other