BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD TRANSFER DEVICE

    MDR report key: 23728712 · Received December 5, 2025

    Report

    Report Number
    2618282-2025-00140
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 6, 2025
    Report Date
    March 10, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    00382903648801
    PMA / PMN Number
    K222478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3: DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 05-DEC-2025. INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES AND 6 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CLOG WAS NOT OBSERVED. THE PHOTOS SHOW THREE (3) BTD DEVICES WITH BLOOD REMAINING IN THE RED HUB AND TWO (2) TYVEK SHOWING BATCH NUMBER 5052241. THE CUSTOMER SAMPLES WERE ANALYZED BY MICROSCOPIC ANALYSIS AND IT WAS OBSERVED THAT THE HUB AND NEEDLE LUMEN WERE UNOBSTRUCTED; HOWEVER, RESIDUAL BLOOD DEPOSITS WERE PRESENT. ADDITIONALLY, 48 RETENTION SAMPLES FROM BD INVENTORY, WERE VISUALLY EVALUATED FOR SLEEVE ASSEMBLY, PIERCED SLEEVE, DEFECTIVE SLEEVE, CLOGGED CANNULA AND FOREIGN MATTER IN NON-PATIENT(NP) CANNULA WITH NO DEFECTS OBSERVED. FURTHERMORE, 12 OF THE RETAIN SAMPLES WERE FUNCTIONALLY EVALUATED FOR LEAKAGE AND ALL SAMPLES TESTED WITHIN SPECIFICATION REQUIREMENTS. 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 CLOG. 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.

    Additional Manufacturer Narrative · 0

    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 3: IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD TRANSFER DEVICE, ONE DEVICE WAS UNABLE TO DISPENSE BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 1 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® BLOOD TRANSFER DEVICE, ONE DEVICE WAS UNABLE TO DISPENSE BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547584 BD VACUTAINER® BLOOD TRANSFER DEVICE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5052241 00382903648801

    Patients

    Seq Age Sex Outcome Treatment
    1