BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD TRANSFER DEVICE

    MDR report key: 24628424 · Received March 18, 2026

    Report

    Report Number
    2618282-2026-00041
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 13, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    00382903648801
    PMA / PMN Number
    K222478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 16-MAR-2026. G.4. PMA / 510(K)#: K991088. INVESTIGATION SUMMARY: 1 SAMPLE AND 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE DEVICE WAS SEALED IN ITS PACKAGING BLISTER SHOWING SMALL BLACK DOTS. THE IMAGES SHOW THE TYVEK WITH PRODUCT INFORMATION INCLUDING CATALOG NUMBER, BATCH NUMBER, AND EXPIRATION DATE. THE BLISTER APPEARS SEALED, CONTAINING AN UNUSED BTD DEVICE. INSIDE THE BLISTER, THERE APPEARS TO BE WHAT LOOKS LIKE SMALL BLACK DOTS. ADDITIONALLY, FORTY-EIGHT (48) RETAIN SAMPLES WERE EVALUATED FOR FOREIGN MATTER AND ZERO UNITS WERE FOUND WITH THE DEFECT. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: FM-UNKNOWN. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SAMPLE COLLECTION USING BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER, THERE WAS FOREIGN MATTER INSIDE THE INDIVIDUAL PACKAGING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SAMPLE COLLECTION USING BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER, THERE WAS FOREIGN MATTER INSIDE THE INDIVIDUAL PACKAGING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349460 BD VACUTAINER® BLOOD TRANSFER DEVICE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5160006 00382903648801

    Patients

    Seq Age Sex Outcome Treatment
    1