BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 8476040 · Received April 2, 2019

    Report

    Report Number
    1920898-2019-00309
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (2) LOOSE 1/2CC, 12.7MM SYRINGES, EACH FILLED WITH APPROXIMATELY 6 UNITS OF A CLEAR LIQUID IN THE BARREL. CUSTOMER STATES THAT FM WAS FOUND IN THE SYRINGE WHEN DRAWING THE DRUG. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED DARK MATERIAL ON THE OUTER SURFACE OF THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE BARREL AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY INK. CAPA 162566 WAS INITIATED TO ADDRESS SUCH ISSUES AT THIS TIME. UNABLE TO PERFORM DHR CHECK DUE TO UNKNOWN LOT NUMBER. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSE IS ATTRIBUTED TO PAD SWELLING ON THE MANDRIL DURING THE PRINTING PROCESS. AS THE PADS ARE USED, THEY GRADUALLY SWELL AND CAN CAUSE THIS TYPE OF "SMEAR" OR "SMUDGE AFFECT. A PROBLEM SOLVING TEAM HAS BEEN TASKED WITH IMPROVING PRINT QUALITY ON ALL PRODUCTION LINES WITHIN THE PLANT. THE TEAM IS SYSTEMATICALLY ASSESSING AND ADDRESSING EACH PRINTER INDIVIDUALLY FOR IMPROVEMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOREIGN MATTER INSIDE TWO BD ULTRA-FINE¿ INSULIN SYRINGE WAS SEEN WHEN DRAWING MEDICATION FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ¿ FM WAS FOUND IN THE SYRINGE WHEN DRAWING THE DRUG. ¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 FOREIGN MATTER INSIDE TWO BD ULTRA-FINE¿ INSULIN SYRINGE WAS SEEN WHEN DRAWING MEDICATION. FOREIGN COMPLAINTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ¿FM WAS FOUND IN THE SYRINGE WHEN DRAWING THE DRUG.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269763 BD ULTRA-FINE INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other