BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ SST¿ CAPILLARY BLOOD COLLECTION TUBE

    MDR report key: 21370123 · Received February 12, 2025

    Report

    Report Number
    2618282-2025-00008
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 4, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903666046
    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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. THE REPORT FOR THE INCIDENT IS CORRECTLY REPORTED UNDER MFR REPORT # 2243072-2025-00073 AND 2243072-2025-00080.

    Additional Manufacturer Narrative · 0

    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 WHILE USING BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS SAMPLE LEAKAGE FROM ONE (1) TUBE. THE PATIENT PASSING OUT AT THE SIGHT OF BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE, THERE WAS SAMPLE LEAKAGE FROM ONE (1) TUBE. THE PATIENT PASSING OUT AT THE SIGHT OF BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984550 BD MINIDRAW¿ SST¿ CAPILLARY BLOOD COLLECTION TUBE CAPILLARY BLOOD COLLECTION TUBE IVD JKA BD CARIBE LTD. 4137840 50382903666046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown