BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 8755580 · Received July 2, 2019

    Report

    Report Number
    2243072-2019-01316
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 9, 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 AND PEN BODY. THIS BATCH NUMBER IS POST TOOL REFURBISHMENT. THE ROOT CAUSE OF THE BROKEN VIAL RETAINER AND PEN BODY 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN II OMNITROPE PEN 10 IS BROKEN. THIS WAS DISCOVERED DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED PEN: PATIENT USES THE OMNI TROPE PEN INJECTOR AND THE PEN IS BROKEN AND DOES NOT WORK THIS IS THE SECOND ONE AND BOTH CRACKED IN THE SAME SPOT. I DID REPORT THE OTHER BROKEN DEVICE AND THEY SENT ME A NEW ONE. IT CRACKED WHERE YOU TWIST THE BLUE AND WHITE PART TOGETHER. THE PARENT SAID THAT THEY DID USE THE DEVICE EVEN THOUGH IT WAS CRACKED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). DEVICE EVALUATED BY MFR: 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 BROKEN. THIS WAS DISCOVERED DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED PEN: PATIENT USES THE OMNI TROPE PEN INJECTOR AND THE PEN IS BROKEN AND DOES NOT WORK THIS IS THE SECOND ONE AND BOTH CRACKED IN THE SAME SPOT. I DID REPORT THE OTHER BROKEN DEVICE AND THEY SENT ME A NEW ONE. IT CRACKED WHERE YOU TWIST THE BLUE AND WHITE PART TOGETHER. THE PARENT SAID THAT THEY DID USE THE DEVICE EVEN THOUGH IT WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548871 PEN II OMNITROPE PEN 10 PEN NEEDLE FMI BECTON DICKINSON 17055002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other