BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 9357081 · Received November 21, 2019

    Report

    Report Number
    2243072-2019-02626
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 27, 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

    INVESTIGATION: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACKED PEN OCCURRED DURING USE WITH A PEN II OMNITROPE PEN 10. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "CONSUMER CALLED TO REPORT THAT HER SON'S OMNITROPE PEN 10 DEVICE HAS CRACKED NEAR WHERE THE CARTRIDGE IS INSERTED. SHE STATED THE CRACK GROWS THE MORE THEY USE IT, AND IT FEELS LOOSER NOW AND DON'T THINK HER SON IS GETTING THE FULL DOSE OF MEDICATION."

    Additional Manufacturer Narrative · 1

    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 A CRACKED PEN OCCURRED DURING USE WITH A PEN II OMNITROPE PEN 10. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER CALLED TO REPORT THAT HER SON'S OMNITROPE PEN 10 DEVICE HAS CRACKED NEAR WHERE THE CARTRIDGE IS INSERTED. SHE STATED THE CRACK GROWS THE MORE THEY USE IT, AND IT FEELS LOOSER NOW AND DON'T THINK HER SON IS GETTING THE FULL DOSE OF MEDICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153978 PEN II OMNITROPE PEN 10 PEN FMI BECTON DICKINSON 18269004 00382904728656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other