BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ FINGER SLEEVE, MEDIUM

    MDR report key: 19636754 · Received June 28, 2024

    Report

    Report Number
    2243072-2024-00763
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    May 6, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GIM
    UDI-DI
    50382903666145
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES D.9. RETURNED TO MANUFACTURER ON: 21-JUN-2024 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2023 INVESTIGATION SUMMARY: BD RECEIVED 10 EXPIRED SAMPLES FOR INVESTIGATION. NEVERTHELESS, THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION FOR FACTORS RELATED TO THE INDICATED FAILURE MODE OF BLOOD POOLING WITH THE INCIDENT LOT. THE ISSUE WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 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

    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, MEDIUM THERE WAS BLOOD POOLING. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ FINGER SLEEVE, MEDIUM THERE WAS BLOOD POOLING. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214813 BD MINIDRAW¿ FINGER SLEEVE, MEDIUM CAPILLARY BLOOD COLLECTION FUNNEL GIM BECTON DICKINSON 1328001 50382903666145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown