BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 20135283 · Received September 4, 2024

    Report

    Report Number
    1416980-2024-04703
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Report Date
    October 15, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081502
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G4: PMA/510K # OR BLA #: UPDATE FROM 'N/A' TO 'K011317'. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH OBSERVED A BROKEN MALE LUER LOCK. THE TUBING LINE SEEMED TO ALSO BE STRETCHED WHILE STILL ATTACHED TO A BROKEN OFF PIECE OF THE LUER LOCK. THERE WAS A DENT ON THE WINGED LUER CAP THAT SUGGESTS IT MAY HAVE BEEN SQUEEZED BY AN UNKNOWN OBJECT WHICH CAUSED THE CAP TO LOOK DEFORMED AS WELL. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE NO. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LUER LOCK PORT FRACTURED. THE LUER FRACTURED INTO TWO PIECES. THE FRACTURE OCCURRED WHEN THE BLUE LID OF THE DEVICE WAS BEING REMOVED BY A NURSING ASSISTANT PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882304 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION 2C9961KP 23J007 00085412081502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.