BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ FINGER SLEEVE, LARGE

    MDR report key: 21808759 · Received April 9, 2025

    Report

    Report Number
    2243072-2025-00488
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    December 5, 2024
    Report Date
    October 30, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GIM
    PMA / PMN Number
    K230391
    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

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ROCHLING MEDICAL ROCHESTER. 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 D2B. MEDICAL DEVICE TYPE: THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: JKA. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K230493. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 26-MAR-2025. INVESTIGATION SUMMARY : BD RECEIVED 19 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE VISUALLY EVALUATED AND THE INDICATED FAILURE MODE FOR BLOOD POOLING WITH THE INCIDENT LOT WAS NOT 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. THE DEVICES WERE 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 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 WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE THERE WAS RESIDUAL BLOOD IN TWO DEVICES. THE SAMPLE WAS RECOLLECTED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE THERE WAS RESIDUAL BLOOD IN TWO DEVICES. THE SAMPLE WAS RECOLLECTED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421651 BD MINIDRAW¿ FINGER SLEEVE, LARGE CAPILLARY BLOOD COLLECTION FUNNEL GIM BECTON DICKINSON 3153001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown