BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG

    MDR report key: 10892803 · Received November 24, 2020

    Report

    Report Number
    1920898-2020-01620
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 29, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917014876
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0202228. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 928850; BATCH NO. 0202228. IT WAS REPORTED THAT CONSUMER IS NOT SURE IF SHE DREW UP AND INJECTED THE CORRECT AMOUNT OF MEDICATION AND MIGHT HAVE TAKEN TOO MUCH. VERBATIM: CONSUMER REPORTED WAS USING A DIFFERENT SIZE 3/10ML INSULIN SYRINGE FOR ALLERGY SHOT AMOUNT .02. SHE WAS GIVEN FROM PHARMACY THE 1ML SUPER THIN INSULIN SYRINGE DID NOT KNOW WHERE TO DRAW TO, DREW DOWN TO 20 UNITS. THINKS SHE MIGHT HAVE TAKEN TOO MUCH NOW. ADVISED CONSUMER TO CALL HER DOCTOR OR PHARMACY TO INFORM OF PROPER USE AND ITEMS.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 928850 BATCH NO. 0202228. IT WAS REPORTED THAT CONSUMER IS NOT SURE IF SHE DREW UP AND INJECTED THE CORRECT AMOUNT OF MEDICATION AND MIGHT HAVE TAKEN TOO MUCH. VERBATIM: CONSUMER REPORTED WAS USING A DIFFERENT SIZE 3/10ML INSULIN SYRINGE FOR ALLERGY SHOT AMOUNT .02. SHE WAS GIVEN FROM PHARMACY THE 1ML SUPER THIN INSULIN SYRINGE DID NOT KNOW WHERE TO DRAW TO, DREW DOWN TO 20 UNITS. THINKS SHE MIGHT HAVE TAKEN TOO MUCH NOW. ADVISED CONSUMER TO CALL HER DOCTOR OR PHARMACY TO INFORM OF PROPER USE AND ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354798 SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 928850 0202228 00311917014876

    Patients

    Seq Age Sex Outcome Treatment
    1