BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL

    MDR report key: 11305090 · Received February 9, 2021

    Report

    Report Number
    1920898-2021-00171
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 19, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    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# 0083446. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL HAD DIFFICULT PLUNGER ROD MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE RUBBER STOPPER IS DIFFICULT TO MOVE. VERBATIM: CONSUMER REPORTED THAT THE RUBBER STOPPER IS DIFFICULT TO MOVE.CONSUMER DOES NOT RE-USE.LOT #: 0083446CATALOG #: 328509DATE OF EVENT: UNKNOWNSAMPLES: AVAILABLE - SENDING MAIL KIT."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL HAD DIFFICULT PLUNGER ROD MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE RUBBER STOPPER IS DIFFICULT TO MOVE. VERBATIM: CONSUMER REPORTED THAT THE RUBBER STOPPER IS DIFFICULT TO MOVE.CONSUMER DOES NOT RE-USE. LOT #: 0083446 CATALOG #: 328509 DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196535 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 0083446 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1