BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 25210616 · Received May 18, 2026

    Report

    Report Number
    2243072-2026-00387
    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) HOSPITAL) 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 50 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO DIFFICULT/UNABLE TO OPERATE AS ALL SAMPLES MET SPECIFICATIONS. ALSO, 8 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO DIFFICULT/UNABLE TO OPERATE AS ALL SAMPLES MET SPECIFICATIONS BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE DIFFICULT/UNABLE TO OPERATE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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.

    Description of Event or Problem · 0

    REPORT 2 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.

    Description of Event or Problem · 0

    REPORT 2 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
    331985 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 25H2081 30382903672975

    Patients

    Seq Age Sex Outcome Treatment
    1