BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 4198418 · Received October 24, 2014

    Report

    Report Number
    9611451-2014-00829
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 24, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED DEVICES: 15 RT021 LOT 131113 - DATE OF MANUFACTURE: 13 NOVEMBER 2013; 18 RT021 LOT 131114 - DATE OF MANUFACTURE: 14 NOVEMBER 2013. METHOD: THIRTY THREE RT021 CATHETER MOUNTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY EXAMINED. RESULTS: VISUAL INSPECTION REVEALED EXCESSIVE GLUE ON 14 (4 FROM LOT 131113 & 10 FROM LOT 131114) OF THE RETURNED RT021 CATHETER MOUNTS. NO FAULT WAS FOUND WITH THE REMAINING 19. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOTS 131113 & 131114. CONCLUSION: ALL RT021 CATHETER MOUNTS ARE VISUALLY INSPECTED SPECIFICALLY FOR EXCESSIVE GLUE. ANY CATHETER MOUNTS THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT021 CATHETER MOUNT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". THE HOSPITAL STAFF CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND CHECKED THE RT021 CATHETER MOUNTS FOR OCCLUSIONS PRIOR TO BEING USED ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT SOME RT021 CATHETER MOUNTS HAD EXCESSIVE GLUE ON THE TUBING CONNECTORS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678192 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 131113

    Patients

    Seq Age Sex Outcome Treatment
    1