BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE PLUS INSULIN SYRINGE

    MDR report key: 8305083 · Received February 5, 2019

    Report

    Report Number
    1920898-2019-00128
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 15, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K955235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (11) 3/10CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 7170866. CUSTOMER STATES THAT THE PLASTIC IS DARK IN COLOR AND THE CAP IS BROKEN. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A BROKEN SHIELD AND ONE SAMPLE EXHIBITED A BROKEN THUMB PRESS. ALSO, 4 OUT OF 11 SAMPLES EXHIBITED DARK MATERIAL SMEARED ON THE OUTER SURFACE OF THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SCALE PRINT INK. SEE ATTACHED PHOTOS AND SPECTRA. CAPA 162566 WAS INITIATED TO ADDRESS SUCH ISSUES AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7170866 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ PLUS INSULIN SYRINGE THERE WAS AN ISSUE WITH THE PLASTIC BEING DARK IN COLOR AND BROKEN CAPS IN PACKAGE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 WITH THE USE OF THE BD MICRO-FINE¿ PLUS INSULIN SYRINGE THERE WAS AN ISSUE WITH THE PLASTIC BEING DARK IN COLOR AND BROKEN CAPS IN PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101987 BD MICRO-FINE PLUS INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7170866

    Patients

    Seq Age Sex Outcome Treatment
    1 Other