BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD OMNITROPE® PEN 10

    MDR report key: 8997032 · Received September 11, 2019

    Report

    Report Number
    2243072-2019-01990
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 23, 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 COMPLAINT SAMPLE REVEALED A CRACKED AND 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 HAS 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

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED UPDATED INFORMATION. THE FOLLOWING FIELDS HAVE BEEN CORRECTED: OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS SANDOZ. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2019-08-09. E.1. INITIAL REPORTER FACILITY NAME: SANDOZ. G.4. DATE RECEIVED BY MANUFACTURER: 2019-08-13. H.3. DEVICE RETURNED TO MANUF.?: YES H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD OMNITROPE® PEN 10 WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PEN CRACKED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD OMNITROPE® PEN 10 WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PEN CRACKED".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NOVARTIS. 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PEN CRACKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794681 BD OMNITROPE® PEN 10 PEN NEEDLE FMI BECTON DICKINSON 18258002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other