BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 10418474 · Received August 17, 2020

    Report

    Report Number
    1920898-2020-01078
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    August 10, 2020
    Report Date
    August 13, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 4327609. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR LABEL INFORMATION MISSING (EXPIRATION DATE) ON LOT # 4327609. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, LABEL INFORMATION MISSING (EXPIRATION DATE) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. AS PER MANUFACTURING: DHRS ARE LEGALLY KEPT FOR 7 YEARS AFTER THE BATCH CREATION DATE. LOT NUMBER 4327609 WAS MANUFACTURED ON JANUARY 2005 (15 YEARS SINCE BATCH CREATION DATE), THUS THE DHR FOR THIS LOT NUMBER IS NO LONGER AVAILABLE. INVESTIGATION CONCLUSION: 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. 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 AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328291 BATCH NO: 4327609. IT WAS REPORTED THAT THE CONSUMER INQUIRED IF INSULIN SYRINGES HAVE AN EXPIRATION DATE. THE CONSUMER STATED SHE HAS SYRINGES THAT ARE ABOUT 15 YEARS OLD WITH NO EXPIRATION DATE AND WOULD LIKE TO KNOW IF SHE CAN USE THEM. VERBATIM: CONSUMER INITIALLY CALLED TO INQUIRE ABOUT WHAT DIABETIC PRODUCTS WOULD BE BEST FOR HER NEEDS. INFORMED OF THE DIFFERENCES WITH THE BD INSULIN SYRINGES AND THE BD PEN NEEDLES. ADVISED CONSUMER THAT IT IS BEST TO CONSULT WITH HER PHARMACIST OR HEALTHCARE PROFESSIONAL TO DETERMINE WHAT WOULD BEST FIT HER NEEDS. CONSUMER INQUIRED IF INSULIN SYRINGES HAVE AN EXPIRATION DATE. STATED SHE HAS SYRINGES THAT ARE ABOUT 15 YEARS OLD WITH NO EXPIRATION DATE AND WOULD LIKE TO KNOW IF SHE CAN USE THEM. STATED SHE CURRENTLY USES AN INSULIN PUMP. ADVISED CONSUMER BD PRODUCTS ARE TESTED FOR 5 YEARS AND IT IS NOT ADVISED TO USE EXPIRED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876647 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 SEE H.10 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other