BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER

    MDR report key: 24876207 · Received April 14, 2026

    Report

    Report Number
    1024879-2026-00553
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    February 18, 2026
    Report Date
    April 28, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903686521
    PMA / PMN Number
    K980414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H.1 IMDRF ANNEX A GRID (1): A140303 - SHORT FILL (1575). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. 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 WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE SAFETY OF AN UNSPECIFIED NUMBER OF DEVICES IS EITHER DIFFICULT TO ENGAGE OR WILL NOT COVER THE NEEDLE TIP. ADDITIONALLY, AN UNSPECIFIED NUMBER OF DEVICES EXHIBITED INSUFFICIENT BLOOD FLOW. 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 WITH PRE-ATTACHED HOLDER, THE SAFETY OF AN UNSPECIFIED NUMBER OF DEVICES IS EITHER DIFFICULT TO ENGAGE OR WILL NOT COVER THE NEEDLE TIP. ADDITIONALLY, AN UNSPECIFIED NUMBER OF DEVICES EXHIBITED INSUFFICIENT BLOOD FLOW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101008 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) UNKNOWN 30382903686521

    Patients

    Seq Age Sex Outcome Treatment
    1