BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-GUARD TB SAFETY SYRINGE

    MDR report key: 18475964 · Received January 9, 2024

    Report

    Report Number
    3014312726-2024-00072
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Report Date
    January 8, 2024
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMF
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    "MEDICAL DEVICE PROBLEM REPORT TO VENDOR REQUEST FOR LOT/COMPLAINTS REVIEW AHS MDIP # 13405 DEVICE AVAILABLE FOR INVESTIGATION: NO AHS MDIP REPORT INCIDENT OR PROBLEM INFORMATION AHS MDIP REFERENCE NUMBER (ID): 13405 DATE OF INCIDENT (YYYY-MM-DD): 2021-06-28 SITE NAME/LOCATION: EDMONTON EXPO CENTRE - HALL C LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES INCIDENT DETAILS: VAIL PUNCTURED WITH SOL-GUARD SAFETY SYINGE WITH FIXED NEEDLE. VIAL INVERTED WITH NEEDLE IN PLACE. PULLED SYINGE BACK AND LIQUID LEAKING FROM WHERE THE NEEDLE CONNECTS TO THE SYRINGE. PULLED SYINGE OUT OF VIAL AND NEEDLE SEPARATED FROM SYINGE. NEEDLE REMAINED STICKING OUT OF VIAL. WHO WAS AFFECTED? NO PERSON AFFECTED FREQUENCY OF PROBLEM: FIRST TIME DEVICE INFORMATION DEVICE NAME/DESCRIPTION: SYRINGE 1ML WITH NEEDLE LDV 25 GAUGE X 1 INCH SOL-GUARD MANUFACTURER: SOL-MILLENNIUM MEDICAL GROUP MANUFACTURER CODE/MODEL: 200034SG SERIAL OR LOT NUMBER: N/A OR UNKNOWN DEVICE EXPIRY DATE (YYYY-MM-DD): N/A OR UNKNOWN. SUPPLIER: PUBLIC HEALTH AGENCY OF CANADA. SUPPLIER CATALOGUE NUMBER: 200034SG. WAS THE DEVICE RETAINED? NO. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682457 SOL-GUARD TB SAFETY SYRINGE SYRINGE FMF SOL-MILLENNIUM MEDICAL INC 200034SG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown