BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANON FOLLISTIM PEN 2ND GEN PEN II

    MDR report key: 9355363 · Received November 21, 2019

    Report

    Report Number
    2243072-2019-02598
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 30, 2019
    Report Date
    November 4, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: UNCONFIRMED, NO SAMPLE RECEIVED. INVESTIGATION CONCLUSION: THE CUSTOMER ISSUED A COMPLAINT FOR CAN¿T INJECT/PEN MALFUNCTION DETECTED DURING USE OF THE PRODUCT BY THE END-USER. ZERO SAMPLES WERE 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. SINCE THE SAMPLE WAS NOT RECEIVED, INVESTIGATION CANNOT BE PERFORMED AS A SAMPLE IS REQUIRED TO INVESTIGATE FURTHER. ROOT CAUSE DESCRIPTION: 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. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORGANON FOLLISTIM PEN 2ND GEN PEN II EXPERIENCED A BROKEN SYRINGE/PEN WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT STATED: "THE PEN WAS NOT WORKING PROPERLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153694 ORGANON FOLLISTIM PEN 2ND GEN PEN II PEN FMI BECTON DICKINSON 18151002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other