BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 10909045 · Received November 26, 2020

    Report

    Report Number
    1920898-2020-01641
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 3, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 # 9231336 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200872529] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200872129, 200872284] NOTED FOR CRACKED HUBS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512, BATCH NO. 9231336. IT WAS REPORTED THAT HE NEEDLE HUB SEPARATED AND THE NEEDLE SHIELD WAS DIFFICULT TO REMOVE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512, BATCH NO. 9231336. IT WAS REPORTED THAT HE NEEDLE HUB SEPARATED AND THE NEEDLE SHIELD WAS DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377814 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 9231336 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1