BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 8696366 · Received June 13, 2019

    Report

    Report Number
    2243072-2019-01175
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 27, 2019
    Report Date
    July 3, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    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 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. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE PEN II OMNITROPE PEN 10 THE HUB IS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED PEN " MY SON'S PEN IS CRACKED, THE WHITE PART WHERE YOU ATTACH THE NEEDLE"

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE PEN II OMNITROPE PEN 10 THE HUB IS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED PEN: " MY SON'S PEN IS CRACKED, THE WHITE PART WHERE YOU ATTACH THE NEEDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490760 PEN II OMNITROPE PEN 10 PEN NEEDLE FMF BECTON DICKINSON 18068001 00382904728656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other