BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 9151746 · Received October 3, 2019

    Report

    Report Number
    1920898-2019-01079
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 18, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    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# 8043556. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION 1920898-2019-01079-1 NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED AN INABILITY/DIFFICULTY ASPIRATING DURING USE, AND A SERIOUS INJURY IN THE FORM OF ELEVATED GLUCOSE LEVELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 324909 BATCH NO.: 8043556. VERBATIM: CONSUMER REPORTED SYRINGE WILL NOT DRAW AND GLUCOSE LEVEL IS HIGH, STATED THAT SHE DOES NOT USE A NEW SYRINGE FOR EACH INJECTION, SAID THERE IS NO NEED TO BECAUSE SHE IS THE ONLY PERSON USING THE SYRINGES. LOT # 8043556 PRODUCT 324910 EXP 03-31-2023 OCCURRENCE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, 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 AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 6MM WHOLE UNIT 10BAG EXPERIENCED AN INABILITY/DIFFICULTY ASPIRATING DURING USE, AND A SERIOUS INJURY IN THE FORM OF ELEVATED GLUCOSE LEVELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: (B)(4) BATCH NO.: 8043556. VERBATIM: CONSUMER REPORTED SYRINGE WILL NOT DRAW AND GLUCOSE LEVEL IS HIGH, STATED THAT SHE DOES NOT USE A NEW SYRINGE FOR EACH INJECTION, SAID THERE IS NO NEED TO BECAUSE SHE IS THE ONLY PERSON USING THE SYRINGES. LOT # 8043556, PRODUCT 324910, EXP 03-31-2023, OCCURRENCE DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948131 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8043556 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other