BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 5521987 · Received March 23, 2016

    Report

    Report Number
    9611451-2016-00111
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    February 11, 2016
    Report Date
    February 23, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT021 IS SOLD IN THE USA BUT HAS NO 510(K) NUMBER AS IT IS CONSIDERED A CLASS I DEVICE. METHOD: ONLY ONE COMPLAINT RT021 CATHETER MOUNT WAS REPORTED BY THE HEALTHCARE FACILITY ON (B)(6) 2016. THE COMPLAINT DEVICE WAS REQUESTED FOR FURTHER EVALUATION BY FISHER & PAYKEL HEALTHCARE. AN INITIAL MEDWATCH FDA REPORT WAS SUBMITTED ON (B)(6) 2016. A FINAL MEDWATCH FDA REPORT WAS SUBMITTED ON (B)(6) 2016. AT THIS STAGE, NO COMPLAINT DEVICE WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE FOR EVALUATION. ON (B)(6) 2016, IN TOTAL SIX RT021 CATHETER MOUNTS (DEVICE 1, DEVICE 2 AND DEVICE 3: LOT INFORMATION 150817, MANUFACTURED ON 17 AUGUST 2015; DEVICE 4, DEVICE 5 AND DEVICE 6: LOT UNKNOWN) WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR EVALUATION WHERE THEY WERE VISUALLY INSPECTED. THEREFORE, THIS MEDWATCH FDA REPORT WAS SUBMITTED AS A FOLLOW-UP REPORT ON (B)(6) 2016. RESULTS: VISUAL INSPECTION OF DEVICE 1 REVEALED THAT THE CONNECTOR DETACHED FROM THE TUBING. A SUFFICIENT AMOUNT OF GLUE WAS FOUND ON THE INSIDE OF THE TUBE CUFF AND ON THE OUTSIDE OF THE CONNECTOR. VISUAL INSPECTION OF DEVICE 2 AND DEVICE 3 REVEALED THAT THE TUBING CUFF OF THE CATHETER MOUNT WAS SPLIT AT THE PROXIMAL END. VISUAL INSPECTION OF DEVICE 4, DEVICE 5 AND DEVICE 6 REVEALED NO DAMAGE THAT COULD HAVE RESULTED IN THE REPORTED DISCONNECTION OF THE CONNECTOR. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE NOTED ON THE RETURNED DEVICE 1. HOWEVER, AS THE COMPLAINT DEVICE WAS RETURNED IN AN UNSEALED BAG, IT IS LIKELY THAT THE RETURNED CATHETER MOUNT BECAME DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION AND AFTER USE BY THE CUSTOMER. BASED ON THE INVESTIGATION CONDUCTED FOR DEVICE 2 AND DEVICE 3, THE SPLIT OBSERVED IS LIKELY DUE TO ENVIRONMENTAL STRESS CRACKING. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED PRIOR TO RELEASE FOR DISTRIBUTION. ANY CATHETER MOUNT WITH A SPLIT TUBE OR DETACHED CONNECTOR WOULD HAVE FAILED THE PRESSURE TEST AND BE REJECTED FROM THE PRODUCTION LINE. THIS SUGGESTS THAT THE RETURNED CATHETER MOUNTS BECAME DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT021 CATHETER MOUNT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER, PREVIOUS SIMILAR INVESTIGATIONS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER REVEALED NO DAMAGE THAT COULD HAVE RESULTED IN THE DISCONNECTION OF THE CONNECTOR. THE CONNECTOR WAS DETACHED FROM THE TUBING IN THE PHOTOGRAPHS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBER PROVIDED BY THE CUSTOMER. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE CUSTOMER. ALL RT021 CATHETER MOUNTS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY DEVICES THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT021 CATHETER MOUNT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE CONNECTOR ON AN RT021 CATHETER MOUNT DETACHED FROM THE TUBE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE CONNECTOR ON AN RT021 CATHETER MOUNT DETACHED FROM THE TUBE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(4) REPORTED THAT THE CONNECTOR ON AN RT021 CATHETER MOUNT DETACHED FROM THE TUBE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177527 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 150817

    Patients

    Seq Age Sex Outcome Treatment
    1