BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP ENDOTRACHEAL TUBE HOLDER PEDIATRIC

    MDR report key: 57022 · Received December 10, 1996

    Report

    Report Number
    2020364-1996-00006
    Event Type
    Injury
    Date Received
    December 10, 1996
    Date of Event
    August 1, 1996
    Report Date
    December 10, 1996
    Manufacturer
    SIMS/RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    CBH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT STATES, "THE ROUND CONNECTOR (LOCK) USED ON H4051 AND H4052 DOES NOT HOLD (THE TUBE) IN PLACE. BECAUSE THE CONNECTOR (LOCK) DOES NOT HOLD THE TUBE WELL, THERE HAVE BEEN 8 EXTUBATIONS (AT OUR FACILITY) DURING THE MONTHS OF AUGUST AND SEPTEMBER. ORAL SECRETIONS WERE NORMAL; THE INACTIVE, NEONATAL PTS, MALES AND FEMALES AGE 0 TO 3 DAYS, WEIGHED BETWEEN 2 TO 4 POUNDS. EXTUBATIONS OCCURRED WITHIN APPROX. 48 HRS AFTER THE INITIAL INTUBATIONS. AFTER THE EXTUBATIONS, THE LOCKS WERE FOUND ATTACHED TO THE CYLINDERS. ANOTHER CO'S TUBES ARE BEING USED. THE INFANTS WERE SUCCESSFULLY RE-INTUBATED. THERE WAS NO EFFECT ON THE PTS OUTCOME." THE DEVICES INVOLVED IN THE EVENTS WERE NOT RETURNED FOR EVALUATION. A SAMPLE ET TUBE HOLDER FROM LOT 904 AND THE OTHER CO TUBE WERE RETURNED FOR EVALUATION. THE FUNCTIONALITY OF THE ET TUBE HOLDER SYSTEM IS NOT BEING CHECKED AT THIS FACILITY IN ACCORDANCE WITH THE DIRECTIONS PROVIDED IN THE PRODUCT INSERT, TO INSURE THAT ONLY STERILE TUBES ARE USED WHEN INTUBATING; HOWEVER, THE LOCK IS CHECKED TO SEE IF IT DOES LOCK. AT THIS POINT IN TIME, INSTEAD OF USING THE LOCKS, THE TUBES ARE BEING HELD WITH TAPE. CO'S PRODUCT INSERT, INS-H405X, REV.C(9-95), STATES (UNDER NUMBERS 2,2A, 2B,5,6, AND 7), "DIRECTIONS FOR USE: 2. TO VERIFY PROPER PERFORMANCE OF THE SYSTEM DO THE FOLLOWING PRIOR TO THE INTUBATION: 2.A) PERFORM 5,6. AND 7 OF DIRECTIONS FOR USE. 5. PLACE TUBE IN CYLINDER SLOT. 6. PLACE SLIP-LOCK OVER TUBE. ALIGN KEYWAY ON SLIP-LOCK WITH SIDE PROTRUSION ON CYLINDER. 7. TO SECURE TUBE SLIDE SLIP-LOCK OVER CYLINDER AND TURN SLIP-LOCK CLOCKWISE. 2.B.) HOLD THE CYLINDER BASE AND MODERATELY PULL THE TUBE TO VERIFY THAT THERE IS NO SLIPPAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP ENDOTRACHEAL TUBE HOLDER PEDIATRIC ENDOTRACHEAL TUBE HOLDER PEDIATRIC CBH SIMS/RESPIRATORY SUPPORT PRODUCTS, INC. H4052 904

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other