BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 8764647 · Received July 5, 2019

    Report

    Report Number
    2243072-2019-01333
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 9, 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

    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 BROKEN VIAL RETAINER. THE ROOT CAUSE OF THE BROKEN VIAL RETAINER IS MOST LIKELY MATERIAL INCOMPATIBILITY. BREAKING 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.BREAKING ON THE VIAL RETAINER 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 BREAKAGE OCCURRED WITH A PEN II OMNITROPE PEN 10. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER CALLED TO ORDER A NEW OMNITROPE PEN , SHE INDICATED THAT HER SON'S PEN IS CRACKED, AND SHE IS NOT SURE HOW IT HAPPENED. AS FOR NOW HE IS STILL ABLE TO GET HIS INJECTIONS, BUT SHE IS CONCERNED THAT HE MAY NOT BE GETTING THE FULL INJECTION."

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BREAKAGE OCCURRED WITH A PEN II OMNITROPE PEN 10. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER CALLED TO ORDER A NEW OMNITROPE PEN , SHE INDICATED THAT HER SON'S PEN IS CRACKED, AND SHE IS NOT SURE HOW IT HAPPENED. AS FOR NOW HE IS STILL ABLE TO GET HIS INJECTIONS, BUT SHE IS CONCERNED THAT HE MAY NOT BE GETTING THE FULL INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559258 PEN II OMNITROPE PEN 10 PEN NEEDLE FMI BECTON DICKINSON 18263003 00382904728656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other