BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 25008766 · Received April 27, 2026

    Report

    Report Number
    1024879-2026-00639
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 11, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    FPA
    UDI-DI
    30382903673422
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS. D.2.B MEDICAL DEVICE TYPE: JKA. D.2.A COMMON DEVICE NAME: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3: DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 10-MAY-2026. H6: IMDRF ANNEX A GRID (2) A140304 - VOLUME ACCURACY PROBLEM (1675), A0414 - MATERIAL SPLIT, CUT OR TORN (2537/2454/3024). BD RECEIVED 4 PHOTOS AND 2 SAMPLES FOR INVESTIGATION. EVALUATION OF THE PHOTOS AND RETURNED SAMPLES INDICATED DAMAGED TUBING, RESULTING IN INSUFFICIENT BLOOD FLOW. ADDITIONALLY, 10 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO DAMAGED TUBING WAS FOUND. 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 MODES: DAMAGED AND INSUFFICIENT BLOOD FLOW. BD HAS INITIATED CORRECTIVE AND PREVENTIVE ACTION TO ADDRESS THE REPORTED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM DAMAGED TUBING OF THE DEVICE, AND INSUFFICIENT BLOOD FLOW ENTERED THE BLOOD COLLECTION TUBE WITH ONE (1) DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM DAMAGED TUBING OF THE DEVICE, AND INSUFFICIENT BLOOD FLOW ENTERED THE BLOOD COLLECTION TUBE WITH ONE (1) DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369399 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON & CO (FRANKLIN LAKES) 5171281 30382903673422

    Patients

    Seq Age Sex Outcome Treatment
    1