BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 10908935 · Received November 26, 2020

    Report

    Report Number
    1920898-2020-01640
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 2, 2020
    Report Date
    January 13, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 2020-12-03. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED TWO (2) LOOSE 0.3ML BD INSULIN SYRINGES. CONSUMER REPORTED HARD TIME TO REMOVE NEEDLE SHIELDS. BOTH RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT BOTH EXHIBITED A NEEDLE HUB/SHIELD ASSEMBLY SEPARATED FROM THE BARREL; NO DAMAGE TO THE BARREL TIPS WAS OBSERVED. CONSUMER REPORTED FOUND 3 SYRINGE FROM THIS BOX WHEN REMOVED SHIELD, NEEDLE HUB REMOVED WITH IT. THE REPORTED NEEDLE STICK ISSUE COULD NOT BE CONFIRMED AS THE SAMPLE THAT CAUSED THE ALLEGED NEEDLE STICK WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200894508] NOTED FOR OUT OF SPEC SHIELD PULL. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE FOR NEEDLE HUB/SHIELD ASSEMBLY SEPARATION. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED NEEDLE STICK ISSUE COULD NOT BE CONFIRMED AS THE SAMPLE THAT CAUSED THE ALLEGED NEEDLE STICK WAS NOT RETURNED. ROOT CAUSE COULD NOT BE DETERMINED CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328291, BATCH NO: 0090638. VERBATIM: CONSUMER REPORTED FOUND 3 SYRINGE FROM THIS BOX WHEN REMOVED SHIELD, NEEDLE HUB REMOVED WITH IT. CONSUMER REPORTED THESE SAME 3 SYRINGES HARD TIME TO REMOVE NEEDLE SHIELDS. CONSUMER REPORTED ONE OF THE SYRINGES WHEN SHE REMOVED THE SHIELD IT WAS SO HARD TO STUCK HER FINGER. SHE IS FINE NO MEDICAL ATTENTION NEEDED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328291, BATCH NO: 0090638. VERBATIM: CONSUMER REPORTED FOUND 3 SYRINGE FROM THIS BOX WHEN REMOVED SHIELD, NEEDLE HUB REMOVED WITH IT. CONSUMER REPORTED THESE SAME 3 SYRINGES HARD TIME TO REMOVE NEEDLE SHIELDS. CONSUMER REPORTED ONE OF THE SYRINGES WHEN SHE REMOVED THE SHIELD IT WAS SO HARD TO STUCK HER FINGER. SHE IS FINE NO MEDICAL ATTENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377714 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 0090638 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1