BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 8MM 1/2CC WALGREENS INSULIN SYRINGE

    MDR report key: 2268001 · Received September 22, 2011

    Report

    Report Number
    1920898-2011-00016
    Event Type
    Injury
    Date Received
    September 22, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 22, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. COMPLAINT HISTORY CHECK YIELDED (1) OTHER COMPLAINT FOR SIMILAR CONDITION FOR THE LOT REPORTED WHICH COULD BE DUPLICATE OF THIS INCIDENT. NO OBVIOUS TRENDS WERE NOTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER CONTACTED (B)(6) REGARDING THE ISSUE. CONSUMER FEELS THAT THE SCALE MARKINGS ARE OFF ON THE SYRINGES. RECENTLY THE PARAMEDICS CAME TO HIS HOME DURING HYPOGLYCEMIC EVENT AND GAVE HIM GLUCOSE POWDER AND AN IV WITH DEXTROSE. CUSTOMER'S SUGAR LEVELED OFF AFTER THE PARAMEDIC TREATMENT. CUSTOMER ADMITS THAT HE REUSES SYRINGES FOUR TIMES. CUSTOMER REPORTED LOT # 0116416 AND LOT # 0181832, BUT DID NOT SPECIFY WHICH LOT WAS INVOLVED IN THE EVENT MENTIONED ABOVE. MDR # 1920898-2011-00017 IS FILED FOR LOT # 0181832.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 8MM 1/2CC WALGREENS INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON NA 0116416

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention