BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 5 1.5ML

    MDR report key: 9162235 · Received October 7, 2019

    Report

    Report Number
    2243072-2019-02218
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 20, 2019
    Report Date
    October 14, 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: 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 CRACKED VIAL RETAINER. THE ROOT CAUSE OF THE CRACKED VIAL RETAINER IS MOST LIKELY MATERIAL INCOMPATIBILITY. CRACKING 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 H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE PEN II OMNITROPE PEN 5 1.5ML HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF FAILURE TO CONTAIN MEDICATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED THAT HIS SON'S OMNITROPE PEN 5 IS BROKE. HE SAID WHEN HE PULLS THE CAP OFF THERE IS A WHITE BAND THAT HAS 2 CRACKS IN IT, AND HE ACTUALLY HAS TO SQUEEZE TO HOLD THE CRACKS TOGETHER TO INJECT THE MEDICATION. HIS SON IS OUT OF MEDICATION AS OF A DAY AGO, HE HAS NOW MISSED ONE OF HIS INJECTIONS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). 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 HAS BEEN REPORTED THAT THE PEN II OMNITROPE PEN 5 1.5ML HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF FAILURE TO CONTAIN MEDICATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED THAT HIS SON'S OMNITROPE PEN 5 IS BROKE. HE SAID WHEN HE PULLS THE CAP OFF THERE IS A WHITE BAND THAT HAS 2 CRACKS IN IT, AND HE ACTUALLY HAS TO SQUEEZE TO HOLD THE CRACKS TOGETHER TO INJECT THE MEDICATION. HIS SON IS OUT OF MEDICATION AS OF A DAY AGO, HE HAS NOW MISSED ONE OF HIS INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958659 PEN II OMNITROPE PEN 5 1.5ML INJECTOR PEN FMI BECTON DICKINSON 18059001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other