BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 28GA 1/2IN

    MDR report key: 11935920 · Received June 3, 2021

    Report

    Report Number
    1920898-2021-00633
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED A PHOTO OF A 1/2CC SYRINGE. CUSTOMER STATES THAT THERE IS A LIQUID IN THE SYRINGES. THE ATTACHED PHOTO WAS EXAMINED AND EXHIBITED A CLEAR DROP OF MATERIAL ON THE CANNULA. IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE ATTACHED PHOTO WITHOUT THE PHYSICAL SAMPLE TO TEST. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132264. 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. THERE WAS ONE (1) NOTIFICATION NOTED FOR EXCESSIVE SILICONE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE ATTACHED PHOTO WITHOUT THE PHYSICAL SAMPLE TO TEST. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 0.5ML 28GA 1/2IN HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED LIQUID IN THE SYRINGES THEMSELVES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER CORRESPONDENCE PHONE# : (B)(6). INITIAL REPORTER CORRESPONDENCE STATE FOR VWR : (B)(6). A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD SYRINGE 0.5ML 28GA 1/2IN HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED LIQUID IN THE SYRINGES THEMSELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829906 SYRINGE 0.5ML 28GA 1/2IN PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0132264

    Patients

    Seq Age Sex Outcome Treatment
    1