BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD MICROCUFF SUBGLOTTIC ET TUBES SAP LEVEL 7

    MDR report key: 5778459 · Received July 8, 2016

    Report

    Report Number
    9611594-2016-00100
    Event Type
    Malfunction
    Date Received
    July 8, 2016
    Date of Event
    June 30, 2016
    Report Date
    August 5, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    BTR
    PMA / PMN Number
    PK131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND EVALUATED. ONE USED 7.5 MICROCUFF SUBGLOTTIC SUCTION TUBE WAS RECEIVED WITH NO PACKAGING. THE PRODUCT DOES NOT CONTAIN A LOT NUMBER IDENTIFICATION. THE CUFF EXHIBITS A PARTIAL RADIAL TEAR, IN THE PROXIMAL SHOULDER AREA. BOTH THE PROXIMAL AND DISTAL CUFF COLLARS REMAIN ATTACHED TO THE TUBING. THE COMPLAINT WAS CONFIRMED FOR A TEAR; HOWEVER, NO ROOT CAUSE COULD BE IDENTIFIED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI # UNKNOWN. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. ROOT CAUSE CANNOT BE DETERMINED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS INTUBATED IN THE EMERGENCY ROOM ON "(B)(6) 2016" AND A LEAK WAS NOTABLE VIA VENT ALARM,; THEREFORE, THE PATIENT WAS RE-INTUBATED. NO FURTHER INFORMATION WAS PROVIDED; HOWEVER, REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434136 HALYARD MICROCUFF SUBGLOTTIC ET TUBES SAP LEVEL 7 VAP MICROCUFF ENDOTRACHEAL TUBES BTR HALYARD HEALTH 13221 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR