BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ FINGER SLEEVE

    MDR report key: 21482511 · Received February 27, 2025

    Report

    Report Number
    2243072-2025-00163
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 24, 2025
    Report Date
    February 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GIM
    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

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ROECHLING MEDICAL ROCHESTER (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. 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: K230391. D4. MEDICAL DEVICE EXPIRATION DATE: NOT APPLICABLE. PRODUCT DOES NOT EXPIRE. D4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC MATERIAL AND LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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, UNKNOWN SIZE, BLOOD POOLING/SMEARING OCCURRED 3 TIMES ON ONE PATIENT. THE SAMPLE WAS RECOLLECTED. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809613 BD MINIDRAW¿ FINGER SLEEVE CAPILLARY BLOOD COLLECTION FUNNEL GIM BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown