BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II MYLAN 3.0ML

    MDR report key: 9218174 · Received October 22, 2019

    Report

    Report Number
    2243072-2019-02343
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 4, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    NSC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ZERO (0) 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. 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 MYLAN 3.0ML WAS DIFFICULT TO OPERATE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019 AT 09:12 AM, AN EMAIL WAS RECEIVED FROM THE PV TEAM WITH AN APOKYN PQC REPORT FROM A COC NURSE. THE REPORT WAS RECEIVED ON (B)(6) 2019 AND STATED, PT STATES THAT HER APOKYN PEN WAS HARD TO DEPRESS THE PLUNGER. COC EVALUATED AND IT WAS DIFFICULT AND IT ALSO FELT LIKE IT "SKIPPED" THROUGH SOME OF THE NOTCHES. FOLLOW-UP INITIAL: ON (B)(6) 2019 AT 01:03 PM, A CALL WAS MADE TO THE CONSUMER TO CONFIRM IF THIS MOST RECENT COMPLAINT WAS THE SAME AS THE ONE RECEIVED ON (B)(6) 2019 (C19-0132) OR (B)(6) 2019 (C19-0157), AND TO CONFIRM IF THE PRODUCT WAS AVAILABLE FOR RETURN. THE CALL WAS DIRECTED TO VOICEMAIL.

    Additional Manufacturer Narrative · 1

    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. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 MYLAN 3.0ML WAS DIFFICULT TO OPERATE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019 AT 09:12 AM, AN EMAIL WAS RECEIVED FROM THE PV TEAM WITH AN APOKYN PQC REPORT FROM A COC NURSE. THE REPORT WAS RECEIVED ON (B)(6) 2019 AND STATED, PT STATES THAT HER APOKYN PEN WAS HARD TO DEPRESS THE PLUNGER. COC EVALUATED AND IT WAS DIFFICULT AND IT ALSO FELT LIKE IT "SKIPPED" THROUGH SOME OF THE NOTCHES. FOLLOW-UP INITIAL: ON 04/OCT/2019 AT 01:03 PM, A CALL WAS MADE TO THE CONSUMER TO CONFIRM IF THIS MOST RECENT COMPLAINT WAS THE SAME AS THE ONE RECEIVED ON 18/JUL/2019 (C19-0132) OR 22/AUG/2019 (C19-0157), AND TO CONFIRM IF THE PRODUCT WAS AVAILABLE FOR RETURN. THE CALL WAS DIRECTED TO VOICEMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015879 PEN II MYLAN 3.0ML PEN NSC BECTON DICKINSON 16218001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other