BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 13388642 · Received January 28, 2022

    Report

    Report Number
    1920898-2022-00046
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 11, 2022
    Report Date
    February 17, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0132186. MEDICAL DEVICE EXPIRATION DATE: 05/31/2025. DEVICE MANUFACTURE DATE: 05/11/2020. MEDICAL DEVICE LOT #: 1011582. MEDICAL DEVICE EXPIRATION DATE: 01/31/2026. DEVICE MANUFACTURE DATE: 01/11/2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/31/2022. H.6. INVESTIGATION: CUSTOMER RETURNED (47) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT THE PLUNGER IS PUSHED TO THE END, THE LIQUID COMES OUT OF THE BARREL. THIRTY OUT OF 47 WERE TESTED AND 18 OUT OF 30 SAMPLES EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT OF THE BARREL WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1011582 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. L2L DISPATCH WAS CREATED FOR SILICONE GUN #4 OUT OF PARAMETERS. THE ESTABLISHED PARAMETERS SET THE AMOUNT OF SILICONE EMITTED INTO THE BARREL. OPERATING ABOVE THE SET PARAMETER MAY LEAD TO A ¿EXCESSIVE SILICONE¿ IN THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED 52 BD ULTRA-FINE INSULIN SYRINGES HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE PLUNGER IS PUSHED TO THE END, THE LIQUID COMES OUT OF THE BARREL."

    Description of Event or Problem · 0

    IT WAS REPORTED 52 BD ULTRA-FINE INSULIN SYRINGES HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE PLUNGER IS PUSHED TO THE END, THE LIQUID COMES OUT OF THE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736094 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown