BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 21447064 · Received February 24, 2025

    Report

    Report Number
    1024879-2025-00206
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 7, 2025
    Report Date
    April 4, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679868
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4220939. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 07-AUG-2024. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K230855. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED ONE (1) VIDEO FOR INVESTIGATION. AFTER REVIEW AND ANALYSIS OF THE CUSTOMER VIDEO, THE CUSTOMER¿S REPORTED DEFECT WAS NOT SEEN. FOR LOT# 4220939 AND LOT# 4220983, 20 RETAINED SAMPLES EACH WERE TESTED FOR FUNCTIONAL TESTS RELATED TO TUBE PUSH OFF, AND NONE OF THE SAMPLES FAILED. AFTER REVIEW AND ANALYSIS OF THE CUSTOMER VIDEO, THE CUSTOMER¿S REPORTED DEFECT WAS NOT OBSERVED WITHIN THE VIDEO. 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 NOT BEEN CONFIRMED FOR THE LOTS 4220939 AND 4220983, FOR THE INDICATED FAILURE MODE: TUBE PUSH OFF. 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 WHILE USING BD VACUTAINER® SST¿, TUBE PUSH-OFF WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES ACROSS TWO LOT NUMBERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, TUBE PUSH-OFF WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES ACROSS TWO LOT NUMBERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402285 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4220983 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown