BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P55

    MDR report key: 9176819 · Received October 10, 2019

    Report

    Report Number
    3003152976-2019-00715
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 23, 2019
    Report Date
    November 26, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151171
    PMA / PMN Number
    K130197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SEVERAL PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR EVALUATION. UPON INSPECTION OF THE PHOTOS, A LEAK WAS OBSERVED BETWEEN THE PROTECTOR AND THE VIAL. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1905123. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PROTECTORS WERE SUCCESSFULLY CONNECTED TO THE VIALS, ENSURING THEY FIT PROPERLY. SAMPLES WERE TESTED FUNCTIONALLY, CONNECTING TO AN INJECTOR AND SYRINGE WITHOUT ISSUES AND NO LEAKS WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. THE PROTECTOR MUST BE ATTACHED COMPLETELY VERTICAL TO THE VIAL. CONCLUSION: BASED ON THE VISUAL INSPECTION OF THE PICTURES RECEIVED IT IS NOT POSSIBLE TO CONFIRM IF THE PROTECTOR WAS PROPERLY CONNECTED TO THE VIAL. NEVERTHELESS, CONSIDERING THAT NO SAMPLES WERE RECEIVED, DHR REVIEW AND LOT RELEASE TESTING DO NOT INDICATE ANY ISSUE AND THE DEFECT COULDN¿T BE DUPLICATED USING THE RETAINED SAMPLES, THE ORIGIN OF THE ROOT CAUSE CANNOT BE LOCATED IN THE MANUFACTURING PROCESS OF THE PROTECTOR P55. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A PROTECTOR P55. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT TWO PROTECTORS LEAKED BETWEEN THE PROTECTOR AND VIAL. EVENT DESCRIPTION PER EMAIL STATES, "WE HAD TWO PROTECTORS LEAK THIS MORNING." 2 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A PROTECTOR P55. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT TWO PROTECTORS LEAKED BETWEEN THE PROTECTOR AND VIAL. EVENT DESCRIPTION PER EMAIL STATES, "WE HAD TWO PROTECTORS LEAK THIS MORNING." 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968391 PROTECTOR P55 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1905123 30382905151171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other