BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG

    MDR report key: 9261707 · Received October 31, 2019

    Report

    Report Number
    1920898-2019-01224
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    September 24, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048154
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 #9063755. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED FOR DAMAGED TIPS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL NO: 928858 ; BATCH NO: 9063755, UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG THE SCALE MARKINGS AT THE TOP OF THE SYRINGE ARE THICKER AND MAKE IT DIFFICULT TO READ AND HAVE THE CORRECT DOSE. DEX COM DEVICE ALARM WENT OFF WITH A GLUCOSE READING OF LESS THAN 40. FOR THE PAST 6 WEEKS MOTHER OF THE CHILD WAKES UP DURING THE NIGHT TO FEED DAUGHTER SUGAR BECAUSE OF BEING CONSISTENTLY LOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER IS FINDING A GOOD AMOUNT WITH THE SCALE MARKINGS THICKER TOWARD THE TOP OF SYRINGE BETWEEN 1/2UNIT MARKER AND 1 1/2UNIT MARKER. MOM STATED HER CHILD (DAUGHTER) USING THE SYRINGE HAS BEEN GETTING CONSISTENT LOW READINGS DURING THE NIGHT FOR THE PAST 6 WEEKS. (B)(6) 2019 DAUGHTERS DEX COM DEVICE ALARM WENT OFF WITH A GLUCOSE READING OF LESS THAN 40. FOR THE PAST 6 WEEKS MOM WAKES UP DURING THE NIGHT TO FEED DAUGHTER SUGAR BECAUSE OF BEING CONSISTENTLY LOW. MOM FEEL THE SCALES BEING THICKER TOWARD THE TOP OF THE SYRINGE IS THROWING THE ACCURACY OF THE DOSE OFF.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9063755, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-03-04. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 928858, BATCH NO: 9063755, UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG THE SCALE MARKINGS AT THE TOP OF THE SYRINGE ARE THICKER AND MAKE IT DIFFICULT TO READ AND HAVE THE CORRECT DOSE. DEX COM DEVICE ALARM WENT OFF WITH A GLUCOSE READING OF LESS THAN 40. FOR THE PAST 6 WEEKS MOTHER OF THE CHILD WAKES UP DURING THE NIGHT TO FEED DAUGHTER SUGAR BECAUSE OF BEING CONSISTENTLY LOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER IS FINDING A GOOD AMOUNT WITH THE SCALE MARKINGS THICKER TOWARD THE TOP OF SYRINGE BETWEEN 1/2UNIT MARKER AND 1 1/2UNIT MARKER. MOM STATED HER CHILD (DAUGHTER) USING THE SYRINGE HAS BEEN GETTING CONSISTENT LOW READINGS DURING THE NIGHT FOR THE PAST 6 WEEKS. 09/24/2019 DAUGHTERS DEX COM DEVICE ALARM WENT OFF WITH A GLUCOSE READING OF LESS THAN 40. FOR THE PAST 6 WEEKS MOM WAKES UP DURING THE NIGHT TO FEED DAUGHTER SUGAR BECAUSE OF BEING CONSISTENTLY LOW. MOM FEEL THE SCALES BEING THICKER TOWARD THE TOP OF THE SYRINGE IS THROWING THE ACCURACY OF THE DOSE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054328 SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00311917048154

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention