BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.3ML 31GX6MM U-100 INSULIN SYRINGE

    MDR report key: 9812315 · Received March 10, 2020

    Report

    Report Number
    1920898-2020-00234
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 19, 2020
    Report Date
    March 17, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : CUSTOMER RETURNED (11) 3/10CC, 6MM, 31G RELION SYRINGES (1 LOOSE, 10 IN A SEALED POLY BAG) FROM LOT # 9140673. CUSTOMER STATES THAT SHE COULD NOT DRAW MEDICATION AND THE NEEDLE CAME OUT IN THE SITE. ALL RETURNED SYRINGES WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. ALL SAMPLES WERE ALSO EXAMINED AND NO BENT, BROKEN, OR SEPARATED CANNULA WAS OBSERVED. ALL SAMPLES ALSO EXHIBITED SUFFICIENT ADHESIVE IN THE HUB WHEN EXAMINED UNDER UV LIGHT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9140673 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200827670, 200827854] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 0.3ML 31GX6MM U-100 INSULIN SYRINGES EXPERIENCED AN INABILITY TO INJECT INSULIN WHILE ANOTHER 0.3ML 31GX6MM U-100 INSULIN SYRINGE EXPERIENCED THE CANNULA BREAKING OFF OR PULLING OUT. THE PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328521 BATCH NO: 9140673 VERBATIM: PET OWNER REPORTED, SHE COULD NOT DRAW MEDICATION, (2 SYRINGES AFFECTED) STATED, WHEN SHE WAS GIVING HER PET HIS INJECTION, THE NEEDLE CAME OUT IN HIS SITE, SHE WAS ABLE TO REMOVE THE NEEDLE, (1 SYRINGE AFFECTED) 1 BOX AFFECTED DATE OF EVENTS: UNKNOWN LOT: 9140673 CATALOG: 328521, (31G, 3/10ML, 6MM).

    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 2 0.3ML 31GX6MM U-100 INSULIN SYRINGES EXPERIENCED AN INABILITY TO INJECT INSULIN WHILE ANOTHER 0.3ML 31GX6MM U-100 INSULIN SYRINGE EXPERIENCED THE CANNULA BREAKING OFF OR PULLING OUT. THE PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328521 BATCH NO: 9140673. VERBATIM: PET OWNER REPORTED, SHE COULD NOT DRAW MEDICATION, (2 SYRINGES AFFECTED) STATED, WHEN SHE WAS GIVING HER PET HIS INJECTION, THE NEEDLE CAME OUT IN HIS SITE, SHE WAS ABLE TO REMOVE THE NEEDLE, (1 SYRINGE AFFECTED). 1 BOX AFFECTED, DATE OF EVENTS: UNKNOWN, LOT: 9140673, CATALOG: 328521, (31G, 3/10ML, 6MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278338 0.3ML 31GX6MM U-100 INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328521 9140673 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other