BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM MANIFOLD SET IN CATH PACK

    MDR report key: 2593975 · Received May 24, 2012

    Report

    Report Number
    1417592-2012-00037
    Event Type
    Other
    Date Received
    May 24, 2012
    Date of Event
    May 2, 2012
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CLINICIAN PRIMED THE MANIFOLD LINES AND ALL CONNECTIONS WERE SECURE PRIOR TO THE INITIATION OF THE PROCEDURE. DURING THE PROCEDURE AIR BUBBLES APPEARED AND SUBSEQUENTLY ENTERED THE PATIENT. THE PATIENT DID NOT SUFFER ANY INJURY AS A RESULT. NAVILYST MEDICAL IS THE MANUFACTURER OF THIS CUSTOM MANIFOLD SET. THEY HAVE BEEN NOTIFIED OF THIS INCIDENT AND WE SENT THEM UNUSED SAMPLES FROM THE SAME REPORTED LOT. AS THE MANUFACTURER OF THIS DEVICE, THEY WILL CONDUCT AN INVESTIGATION AND DETERMINE THE NEED FOR ANY CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC PROCEDURE, AIR BUBBLES WERE SEEN IN THE MANIFOLD SET AND SUBSEQUENTLY ENTERED THE PATIENT. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM MANIFOLD SET IN CATH PACK DTL NAVILYST MEDICAL 4241289

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention