BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

    MDR report key: 21526415 · Received March 5, 2025

    Report

    Report Number
    2243072-2025-00206
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    January 31, 2025
    Report Date
    October 2, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: B.5 IT WAS REPORTED THAT WHEN USING BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE IS WAS BLOOD POOLING IN 2 DEVICES AND BLOOD LEAKAGE IN 1 DEVICE. ADDITIONALLY ONE DEVICE WAS REPORTED TO BE DIFFICULT TO CONNECT A COLLECTION TUBE TO THE DEVICE CONNECTOR. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. H.6 IMDRF ANNEX A GRID: A1208 - FITTING PROBLEM (2183).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE IS BLOOD SMEARING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE IS WAS BLOOD POOLING IN 2 DEVICES AND BLOOD LEAKAGE IN 1 DEVICE. ADDITIONALLY ONE DEVICE WAS REPORTED TO BE DIFFICULT TO CONNECT A COLLECTION TUBE TO THE DEVICE CONNECTOR. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315264 BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 3233001 50382903666169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown