BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP ENDOTRACHEAL TUBE HOLDER

    MDR report key: 280057 · Received May 25, 2000

    Report

    Report Number
    2020364-2000-00007
    Event Type
    Other
    Date Received
    May 25, 2000
    Date of Event
    May 15, 2000
    Report Date
    May 23, 2000
    Manufacturer
    SIMS/RESPIRATORY SUPPORT PRDTS.
    Product Code
    CBH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED, "WHEN THE NURSE CHECKED THE PT, SEDATED MALE), IT WAS OBSERVED THAT THE LOCK HAD BECOME UNLOCKED FROM THE CYLINDER AND HAD TRAVELED UP THE TUBE. THE PT HAD ACCIDENTALLY EXTUBATED (THE TUBE HAD MOVED OUTWARD 1.5 INCHES). THE HOSP USES "RSP" TUBES AS WELL AS SHERIDAN BRAND TUBES WITH "RSP" HOLDERS. THE HOLDER WAS STILL ADHERED TO THE PT'S FACE. THE HOLDER WAS SAVED BUT WAS NOT RETURNED FOR EVAL. THE TUBE WAS NOT SAVED. ORAL SECRETIONS WERE AVERAGE. THE PT IS SUCTIONED FREQUENTLY. THE PT WAS RE-INTUBATED WITHOUT INCIDENT. THERE ARE NO NEW PERSONNEL IN THE NICU AREA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP ENDOTRACHEAL TUBE HOLDER ENDOTRACHEAL TUBE HOLDER CBH SIMS/RESPIRATORY SUPPORT PRDTS. H4052 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 DAY Other