BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BRAZIL

    MDR report key: 12062971 · Received June 24, 2021

    Report

    Report Number
    1911916-2021-00595
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION SUMMARY: TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A SECTION OF AN INVOICE WHERE THE MANUFACTURING DATE IS 2021-01-13 (JANUARY 13, 2021) AND THE EXPIRATION DATE IS 2025-12-31 (DECEMBER 31, 2025). THE OTHER PHOTO SHOWS A BOX LABEL SHOWING THE FAB/EST (MANUFACTURING DATE) 2021-02-07 (FEBRUARY 07, 2021). A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT NUMBER 1013547. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND THE PHOTO SAMPLES PROVIDED IT IS CONFIRMED THAT THIS IS A MISINTERPRETATION OF THE MANUFACTURING DATES. ROOT CAUSE DESCRIPTION: THE MANUFACTURING DATE ON THE BOX LABEL IS 2021-02-07 (YYYY-MM-DD = 2021-FEB-07) HOWEVER, THE CUSTOMER IS REPORTING THAT THEIR UNDERSTANDING IS "ACCORDING TO THE LABEL ON THE BOX - MANUFACTURING WAS ON 2021-02-07." IT IS UNCLEAR WHICH DISTRIBUTOR ISSUES THE INVOICE AND THE INFORMATION USED. THE LABELS ARE CORRECT, NOT THE INVOICE. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BOX OF SYRINGE 50ML LL (B)(6) HAD AN INCORRECT EXPIRATION DATE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE PACKAGING ONLY CONTAINS THE DATE OF MANUFACTURE AND INFORMATION VALID FOR 5 YEARS (VALID: 5 YEARS FROM DATE OF MANUFACTURE/STERILIZATION). ACCORDING TO THE LABEL ON THE BOX - MANUFACTURING: IT WAS ON 02/FEB/2021. IN THIS WAY, THE CLIENT UNDERSTANDS THAT THE VALIDITY SHOULD BE ON 07/FEB/2026. HOWEVER, THE INVOICE STATES EXPIRATION DATE 31/DEC/2025 AND MANUFACTURING DATE 13/JAN/2021."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952556 SYRINGE 50ML LL BRAZIL PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1013547

    Patients

    Seq Age Sex Outcome Treatment
    1