BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 8875071 · Received August 8, 2019

    Report

    Report Number
    2243072-2019-01639
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 30, 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 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 OF THE RETURNED COMPLAINT SAMPLE REVEALED CRACKED VIAL RETAINER. THIS BATCH NUMBER IS POST TOOL REFURBISHMENT. THE ROOT CAUSE OF THE CRACKED VIAL RETAINER IS MOST LIKELY MATERIAL INCOMPATIBILITY. CRACKING FROM MATERIAL INCOMPATIBILITY IS DUE TO THE INTERACTION BETWEEN THE POLYCARBONATE OF THE VIAL RETAINER COMPONENT AND DIOCTYL PHTHALATE FOUND IN THE PEN POUCH. CHEMICAL COMPATIBILITY OVERVIEW FOR LEXAN POLYCARBONATE RECOMMENDS AGAINST THE USE OF DIOCYTL PHTHALATE IN CONJUNCTION WITH POLYCARBONATE AS IT RESULTS IN FAILURE OR SEVERE DEGRADATION. CORRECTIVE ACTIONS HAVE BEEN DETERMINED TO INFORM SANDOZ GMBH OF MATERIAL COMPATIBILITY WITH THE PEN POUCH. PREVENTATIVE ACTION HAS BEEN ESTABLISHED FOR SANDOZ TO UPDATE THE PEN POUCH MATERIAL. BASED ON ANALYSIS AND STUDIES THAT HAVE BEEN SUMMARIZED IN ¿SANDOZ OMNITROPE® PEN 5 & OMNITROPE® PEN 10 PEN CRACK ROOT CAUSE INVESTIGATION¿ (DATED 15-JUNE-2016) ONE POTENTIAL ROOT CAUSE HAVE BEEN IDENTIFIED. 1.CRACKING ON THE VIAL RETAINER AND PEN BODY FROM MATERIAL INCOMPATIBILITY IS DUE TO THE INTERACTION BETWEEN THE POLYCARBONATE OF THE PEN COMPONENTS AND DIOCTYL PHTHALATE FOUND IN THE PEN POUCH. SANDOZ HAS BEEN INFORMED OF THE MATERIAL COMPATIBILITY ISSUE BY BD. SANDOZ HAS INFORMED BD THAT THE POUCH WILL BE UPDATED BY MIDDLE OF 2019. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN II OMNITROPE PEN 10 IS CRACKING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS STATED THAT: ¿ACCORDING TO THE CUSTOMER THE PEN WAS LOOSE DURING INJECTION AND THE PEN IS CRACKING THE "CLOSING RING.¿

    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 (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. 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 IS CRACKING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS STATED THAT: ¿ACCORDING TO THE CUSTOMER THE PEN WAS LOOSE DURING INJECTION AND THE PEN IS CRACKING THE "CLOSING RING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671129 PEN II OMNITROPE PEN 10 PEN FMI BECTON DICKINSON 16174001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other