BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 21244519 · Received January 27, 2025

    Report

    Report Number
    1024879-2025-00040
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    December 29, 2024
    Report Date
    May 12, 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

    INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. AFTER REVIEW AND ANALYSIS OF THE CUSTOMER PHOTO, HEMOLYSIS IS SEEN ON THE TUBE ON THE RIGHT SIDE OF THE PHOTO. TWO BATCHES WERE MENTIONED IN THE COMPLAINT, BUT ONLY ONE DEFECTIVE TUBE WAS PHOTOGRAPHED, AND IT IS NOT INDICATED WHICH BATCH THE DEFECTIVE TUBE BELONGS TO. THEREFORE, BD WILL ASSUME THE DEFECT APPLIES TO BOTH BATCHES. A TOTAL OF 30 RETAINED SAMPLES FOR BATCH: 4199749 WERE VISUALLY INSPECTED, AND NONE OF THE SAMPLES SHOWED ADDITIVE DEFECTS. SIMILARLY, A TOTAL OF 30 RETAINED SAMPLES FOR BATCH: 4173403 WERE VISUALLY INSPECTED, AND NONE OF THE SAMPLES SHOWED ANY VISUAL DEFECTS. 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 LOTS 4173403 AND 4199749, FOR THE INDICATED FAILURE MODE: HEMOLYSIS BASED ON CUSTOMER PHOTO 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.

    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#: 4173403. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 21-JUN-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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 7 TUBES ACROSS TWO LOT NUMBERS EXHIBITED HEMOLYSIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 7 TUBES ACROSS TWO LOT NUMBERS EXHIBITED HEMOLYSIS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780872 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4199749 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown