BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 8647290 · Received May 28, 2019

    Report

    Report Number
    2243072-2019-01026
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 9, 2019
    Report Date
    June 18, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382904728656
    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

    INVESTIGATION SUMMARY: 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 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 DURING USE OF THE PEN II OMNITROPE PEN 10 STARTED TO MALFUNCTION SPRING WAS JAMMED AND COULD NOT PUSH DOWN. WHEN ADMINISTERING OMNITROPE PEN JAMMED HALFWAY THROUGH INJECTION AND MAYBE HALF OF THE DOSE WAS ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER STUCK: ¿STARTED MALFUNCTIONING 4 DAYS AGO". HE ADDED THAT HE "CANNOT PUSH IT DOWN" AND THAT THE "SPRING GOT JAMMED". DUE TO THE ISSUE, HE WAS NOT ABLE TO GIVE HIS DAUGHTER HER OMNITROPE "YESTERDAY". HE REPORTED THAT THE PEN "JAMMED HALFWAY THROUGH" WHEN TRYING TO ADMINISTER A DOSE. HE ADDED THAT "HALF" OF THE DOSAGE MAY HAVE BEEN ADMINISTERED, BUT COULD NOT BE CERTAIN. HE TRIED THE PEN AGAIN AND STATED IT "JAMMED". HE DID NOT TRY TO GIVE OMNITROPE YESTERDAY AS HE DID NOT WANT TO "PRICK" HIS DAUGHTER WITH THE NEEDLE IF IT IS MALFUNCTIONED AS IT "HURTS HER".

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE PEN II OMNITROPE PEN 10 STARTED TO MALFUNCTION SPRING WAS JAMMED AND COULD NOT PUSH DOWN. WHEN ADMINISTERING OMNITROPE PEN JAMMED HALFWAY THROUGH INJECTION AND MAYBE HALF OF THE DOSE WAS ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER STUCK: ¿STARTED MALFUNCTIONING 4 DAYS AGO". HE ADDED THAT HE "CANNOT PUSH IT DOWN" AND THAT THE "SPRING GOT JAMMED". DUE TO THE ISSUE, HE WAS NOT ABLE TO GIVE HIS DAUGHTER HER OMNITROPE "YESTERDAY". HE REPORTED THAT THE PEN "JAMMED HALFWAY THROUGH" WHEN TRYING TO ADMINISTER A DOSE. HE ADDED THAT "HALF" OF THE DOSAGE MAY HAVE BEEN ADMINISTERED, BUT COULD NOT BE CERTAIN. HE TRIED THE PEN AGAIN AND STATED IT "JAMMED". HE DID NOT TRY TO GIVE OMNITROPE YESTERDAY AS HE DID NOT WANT TO "PRICK" HIS DAUGHTER WITH THE NEEDLE IF IT IS MALFUNCTIONED AS IT "HURTS HER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438127 PEN II OMNITROPE PEN 10 PEN NEEDLE FMI BECTON DICKINSON 15338004 00382904728656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other