BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 8696249 · Received June 13, 2019

    Report

    Report Number
    2243072-2019-01174
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 8, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE (1) SAMPLE WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCH INVOLVED IN THIS COMPLAINT MEETS ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WAS MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. INITIAL EVALUATION REVEALED NO VISIBLE DAMAGE TO THE PEN. THE SAMPLE WAS TESTED FOR FUNCTIONALITY THROUGH DOSE SET KNOB (DSK) PUSH FORCE TEST (TEST INSTRUCTION IT1182) AND BY PERFORMING SAMPLE INJECTIONS. THE RETURNED COMPLAINT PEN MET DSK PUSH FORCE TEST SPECIFICATION. THE PEN FUNCTIONED AS INTENDED DURING THE SAMPLE INJECTIONS. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN II OMNITROPE PEN 10 WAS NOT WORKING AND WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOTHER CALLED IN AND STATES THAT HER SONS PEN DEVICE IS NOT WORKING, THEY HAD IT FOR A LONG TIME AND MOTHER STATES THAT SHE DOESN'T THINK HER SON IS OBTAINING THE CORRECT AMOUNT OF MEDICATION. MOTHER CONFIRMED ADDRESS AND PEN DEVICE SIZE AS A PEN 10.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). DEVICE EVALUATED BY MFR: 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 PEN II OMNITROPE PEN 10 WAS NOT WORKING AND WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOTHER CALLED IN AND STATES THAT HER SONS PEN DEVICE IS NOT WORKING, THEY HAD IT FOR A LONG TIME AND MOTHER STATES THAT SHE DOESN'T THINK HER SON IS OBTAINING THE CORRECT AMOUNT OF MEDICATION. MOTHER CONFIRMED ADDRESS AND PEN DEVICE SIZE AS A PEN 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490557 PEN II OMNITROPE PEN 10 PEN NEEDLE FMI BECTON DICKINSON 16179002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other