BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 20872214 · Received December 6, 2024

    Report

    Report Number
    1024879-2024-01201
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 13, 2024
    Report Date
    April 8, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679899
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K230855. INVESTIGATION SUMMARY: MATERIAL #: 367989 LOT/BATCH #: UNKNOWN BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES H.3 DEVICE EVALUTION BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 16-DEC-2024 INVESTIGATION SUMMARY BD RECEIVED ONE (1) PHOTO AND THREE (3) SAMPLES FOR INVESTIGATION. THE ANALYSIS OF THE CUSTOMER PHOTO REVEALED THREE SAMPLES WITH NO LOT NUMBER ON THE TUBE. A VISUAL INSPECTION OF THE SAMPLES WAS CONDUCTED, AND THREE TUBES WERE SEEN WITH NO LABEL ATTACHED. ADDITIONALLY, A TOTAL OF 90 RETAINED SAMPLES, 30 FOR EACH PROBABLE LOT NUMBER (4094970, 4094971 AND 4123520) WERE VISUALLY INSPECTED FOR MISSING LABELS, AND NONE OF THE RETAINED SAMPLES FAILED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE MISSING LABEL CONTENT BASED ON CUSTOMER PHOTO AND RETURNED SAMPLE ANALYSIS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD VACUTAINER® SST¿ THERE WAS A MISSING TUBE LABEL ON 3 DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD VACUTAINER® SST¿ THERE WAS A MISSING TUBE LABEL ON 3 DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516498 BD VACUTAINER® SST¿ EVACUATED BLOOD COLLECTION TUBE IVD, CLOT ACTIVATOR/SEPARATOR JKA BECTON, DICKINSON & CO., (BD) UNKNOWN 30382903679899

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown