BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

    MDR report key: 23411685 · Received October 29, 2025

    Report

    Report Number
    2243072-2025-01320
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    January 7, 2025
    Report Date
    October 3, 2025
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    50382903666169
    PMA / PMN Number
    K230493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: ADDITIONAL MEDICAL DEVICE TYPE: GIM. G5: ADDITIONAL PMA / 510(K)#: K230391. INVESTIGATION SUMMARY: BD RECEIVED 35 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE NOT EVALUATED AS THE CUSTOMER STATED THEY CONCLUDED THAT THE ISSUE OF BLOOD POOLING IS NOT RELATED TO THE PRODUCT BEING DEFECTIVE, BUT RATHER COLLECTION TECHNIQUES INCLUDING FINGER ALIGNMENT AND FINGER SIZING. RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY BOTH VISUAL EXAMINATION AND FUNCTIONAL TESTING, AND NO ISSUES WERE OBSERVED RELATING TO BLOOD POOLING. THE DEVICE WAS MANUFACTURED ACCORDING TO PRODUCT 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 BLOOD POOLING. BD WAS ABLE TO TRACE THE ROOT CAUSE FOR THE INDICATED FAILURE MODE TO USER TECHNIQUE. AS PART OF BD'S ONGOING PROCESS TO TRACK AND TREND COMPLAINT DATA, AN UPDATE TO THE MINIDRAW EIFU WAS INITIATED TO ADDRESS THE RESIDUAL BLOOD IN FINGER SLEEVES THAT MAY OCCUR. THE NEW VERBIAGE IN THE WARNING SECTION WILL STATE: "PRACTICE UNIVERSAL PRECAUTIONS IN ACCORDANCE WITH YOUR FACILITY¿S PROCEDURES. USE GLOVES, GOWNS, EYE PROTECTION, OTHER PERSONAL PROTECTIVE EQUIPMENT, AND ENGINEERING CONTROLS TO PROTECT FROM RESIDUAL BLOOD ON FINGER AND/OR FINGER SLEEVE, BLOOD SPLATTER, BLOOD LEAKAGE, AND POTENTIAL EXPOSURE TO BLOOD-BORNE PATHOGENS." ADDITIONALLY, THE NEW TEXT IN STEP 8 OF THE BLOOD COLLECTION PROCEDURE WILL STATE: "RESIDUAL BLOOD MAY BE PRESENT ON PATIENT'S FINGER AND/OR FINGER SLEEVE."

    Description of Event or Problem · 0

    REPORT 5 OF 5: IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS ONE INSTANCE OF BLOOD POOLING IN THE FINGER SLEEVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211246 BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE CAPILLARY BLOOD COLLECTION FUNNEL JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 3233001 50382903666169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown