BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 8620309 · Received May 17, 2019

    Report

    Report Number
    2243072-2019-00958
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 2, 2019
    Report Date
    June 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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN II OMNITROPE PEN 10 INJECTED THE MEDICINE VERY SLOWLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOTH PENS INJECTED THE MEDICINE VERY SLOWLY AND I HAD TO PRESS MULTIPLE TIMES FOR THE WHOLE DOSE TO BE DISPENSED WHICH MADE MY SON SCREAM FROM PAIN. I RETURNED THE EXTRA MEDICINE BECAUSE I DIDN'T KNOW IF YOU NEED ALL WHAT WAS IN MY POSSESSION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS SANDOZ. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) NJ HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 INJECTED THE MEDICINE VERY SLOWLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOTH PENS INJECTED THE MEDICINE VERY SLOWLY AND I HAD TO PRESS MULTIPLE TIMES FOR THE WHOLE DOSE TO BE DISPENSED WHICH MADE MY SON SCREAM FROM PAIN. I RETURNED THE EXTRA MEDICINE BECAUSE I DIDN'T KNOW IF YOU NEED ALL WHAT WAS IN MY POSSESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411817 PEN II OMNITROPE PEN 10 PEN NEEDLE FMI BECTON DICKINSON 18068001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other