BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN II OMNITROPE PEN 10

    MDR report key: 8624431 · Received May 20, 2019

    Report

    Report Number
    2243072-2019-00969
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 12, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    NSC
    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 BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. INITIAL EVALUATION OF THE COMPLAINT SAMPLE REVEALED A 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..10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN II OMNITROPE PEN 10 EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED PEN: ¿BROKEN PEN¿.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN II OMNITROPE PEN 10 EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED PEN: ¿BROKEN PEN¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416316 PEN II OMNITROPE PEN 10 INSULIN PEN NSC BECTON DICKINSON 16306003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other