BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD OMNITROPE® PEN 10

    MDR report key: 8753033 · Received July 2, 2019

    Report

    Report Number
    2243072-2019-01308
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 10, 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 BROKEN VIAL RETAINER. THE COMPLAINT SAMPLE COULD NOT BE TESTED FOR THE REPORTED ISSUE OF DRIPPING PEN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD OMNITROPE® PEN 10 LEAKED "1-5 DROPS" OF MEDICATION DURING USE AND AFTER THE INJECTION HAD BEEN GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PEN IS LEAKING 1-5 DROPS AFTER INJECTION IS GIVEN".

    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 THE BD OMNITROPE® PEN 10 LEAKED "1-5 DROPS" OF MEDICATION DURING USE AND AFTER THE INJECTION HAD BEEN GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PEN IS LEAKING 1-5 DROPS AFTER INJECTION IS GIVEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545922 BD OMNITROPE® PEN 10 PEN NEEDLE FMI BECTON DICKINSON 15338004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other