BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9554459 · Received January 6, 2020

    Report

    Report Number
    1911916-2019-01372
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 20, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED FOR EVALUATION. THE PHOTO SHOWS A TRAY WITH A VIAL (SMALL GLASS BOTTLE) AND A 10ML SYRINGE WITH A NEEDLE ASSEMBLY CONNECTED TO IT. FROM THE PHOTO WE CAN¿T SEE ANY FOREIGN MATTER (FM) IN THE SYRINGE. IT MAY BE THERE, WE JUST CAN¿T SEE IT FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER INSIDE THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106 BATCH NO: 8250581 IT WAS REPORTED THAT AFTER THE PROVIDER WITHDREW THE MEDICATION INTO THE SYRINGE, A HAIR FOLLICLE WAS NOTICED IN THE MEDICATION IN THE SYRINGE. PER THE REPORTER, "LAST WEEK," AFTER THE PROVIDER WITHDREW THE MEDICATION INTO THE SYRINGE, HE NOTICED A HAIR FOLLICLE IN THE MEDICATION IN THE SYRINGE. THE MEDICATION WAS NOT USED. THE PATIENT SUCCESSFULLY RECEIVED A DOSE FROM A NEW EYLEA KIT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER INSIDE THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106, BATCH NO: 8250581. IT WAS REPORTED THAT AFTER THE PROVIDER WITHDREW THE MEDICATION INTO THE SYRINGE, A HAIR FOLLICLE WAS NOTICED IN THE MEDICATION IN THE SYRINGE. PER THE REPORTER, "LAST WEEK," AFTER THE PROVIDER WITHDREW THE MEDICATION INTO THE SYRINGE, HE NOTICED A HAIR FOLLICLE IN THE MEDICATION IN THE SYRINGE. THE MEDICATION WAS NOT USED. THE PATIENT SUCCESSFULLY RECEIVED A DOSE FROM A NEW EYLEA KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19169 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 8250581 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other