BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 10840765 · Received November 13, 2020

    Report

    Report Number
    1920898-2020-01566
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 22, 2020
    Report Date
    January 26, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 NOTIFICATION [200894508] NOTED FOR OUT OF SPEC SHIELD PULL. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, SHIELD IS DIFFICULT TO REMOVE. STATED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. LOT: 0090638. CATALOG: 328291. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, SHIELD IS DIFFICULT TO REMOVE. STATED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. LOT: 0090638, CATALOG: 328291, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305924 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