BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 25095040 · Received May 6, 2026

    Report

    Report Number
    1024879-2026-00718
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 11, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903686538
    PMA / PMN Number
    K980414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN 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)#: K252506 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 DID NOT RECEIVE ANY SAMPLES OR PHOTOS FOR INVESTIGATION. TESTING OF RETAINED SAMPLES COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE BATCH NUMBER IS UNKNOWN. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODES: DIFFICULT/UNABLE TO OPERATE AND NEEDLE POINT INTEGRITY. 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 THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY MECHANISM OF AN UNSPECIFIED NUMBER OF DEVICES WAS HARD TO ACCESS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY MECHANISM OF AN UNSPECIFIED NUMBER OF DEVICES WAS HARD TO ACCESS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121051 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) UNKNOWN 30382903686538

    Patients

    Seq Age Sex Outcome Treatment
    1