BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 25210617 · Received May 18, 2026

    Report

    Report Number
    2243072-2026-00388
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903672975
    PMA / PMN Number
    K252506
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NIPRO. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. E.1. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K980414. 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

    REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, ONE DEVICE'S SAFETY MECHANISM FAILED TO ENGAGE AND RESULTED IN A DIRTY NEEDLESTICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:"AFTER OBTAINING A BLOOD SAMPLE FROM A PT, WHEN THE SAFETY MECHANISM FAILED TO ENGAGE PROPERLY RESULTING IN TRYING TO DISCARD THE SHARP INTO THE SHARPS CONTAINER ON THE WALL IN THE ROOM. WAS IT A CLEAN NEEDLE OR A USED NEEDLE: USED WHERE WAS THE INJURY: RIGHT HAND, 2ND DIGIT WAS THE PROPER TECHNIQUE USED: PROPER TECHNIQUE FOR OBTAINING BLOOD SPECIMENS USED BUT UNABLE TO ACTIVATE THE SAFETY MECHANISM. WAS MEDICAL INTERVENTION REQUIRED OR NECESSARY: LAB WORK OBTAINED FOR MYSELF AND FROM PT PER NEEDLE STICK POLICY" THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529308 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 25H3181 30382903672975

    Patients

    Seq Age Sex Outcome Treatment
    1