BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 2488692 · Received March 12, 2012

    Report

    Report Number
    1119193-2012-00003
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    February 13, 2012
    Report Date
    March 12, 2012
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO DETERMINE THE CAUSE OF THE ANCHORFAST CLAMP BREAKAGE AND RESULTING EXTUBATION. THERE ARE MANY FACTORS THAT COULD CAUSE THE CLAMP TO BREAK. WITHOUT THE ACTUAL DEVICE OR PICTURES OF THE ACTUAL DEVICE, WE ARE NOT ABLE TO DETERMINE THE CAUSE. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT ALL PARAMETERS AND TEST DATA WERE WITHIN SPECIFICATION REQUIREMENTS. NO ADVERSE PRODUCT PERFORMANCE TRENDING HAS BEEN OBSERVED. DATA WILL CONTINUE TO BE MONITORED. THIS REPORT OR INFORMATION SUBMITTED DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, HOLLISTER INCORPORATED, OR HOLLISTER EMPLOYEE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCESS OF TURNING THE PATIENT, THE CLAMP ON THE ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER SNAPPED AWAY FROM THE SLIDING PART. THE PATIENT WAS EXTUBATED AS A RESULT AND HAD NO SPONTANEOUS RESPIRATIONS. RE-INTUBATION WAS REQUIRED. THE ANCHORFAST HAD BEEN IN PLACE FOR APPROXIMATELY 1 HOUR AT THE TIME OF THE BREAKAGE. IT WAS STATED THAT THE USER DID NOT BELIEVE THAT AN EXCESSIVE AMOUNT OF PRESSURE WAS PUT ON THE DEVICE. THE PATIENT WAS SAID TO HAVE REQUIRED AN ADDITIONAL 8 TO 10 HOURS OF INTUBATION TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799 1F102

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R