BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 24840270 · Received April 10, 2026

    Report

    Report Number
    3004122598-2026-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 10, 2026
    Manufacturer
    PRODUCTOS MEDLINE S.A. DE C.V.
    Product Code
    OIB
    UDI-DI
    10195327576257
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED ON (B)(6) 2026 THAT DURING A WHOLE BLOOD PHLEBOTOMY PROCEDURE, HOLES WERE DISCOVERED IN BLOOD COLLECTION TEST TUBES. THE DEFECT WAS IDENTIFIED WHILE FILLING THE TEST TUBES FROM THE DIVERSION POUCH. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2026 THAT DURING A WHOLE BLOOD PHLEBOTOMY PROCEDURE, HOLES WERE DISCOVERED IN BLOOD COLLECTION TEST TUBES. THE DEFECT WAS IDENTIFIED WHILE FILLING THE TEST TUBES FROM THE DIVERSION POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899993 MEDLINE WHOLE BLOOD DRAW PHLEBOTOMY OIB PRODUCTOS MEDLINE S.A. DE C.V. 25LBE089 10195327576257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown