BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

    MDR report key: 21643121 · Received March 19, 2025

    Report

    Report Number
    2243072-2025-00328
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 19, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903666169
    PMA / PMN Number
    K230493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDR 1: (B)(6). D2B: ADDITIONAL MEDICAL DEVICE TYPE: GIM. G5: ADDITIONAL PMA / 510(K)#: K230391. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS RMR. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR OF BLOOD POOLING WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY BOTH VISUAL EXAMINATION AND FUNCTIONAL TESTING, AND NO ISSUES WERE OBSERVED RELATING TO BLOOD POOLING. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE BLOOD POOLING. BD WAS NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, BLOOD IS POOLING IN TWO (2) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, BLOOD IS POOLING IN TWO (2) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640374 BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 3233001 50382903666169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown