BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6420732 · Received March 21, 2017

    Report

    Report Number
    9681900-2017-00017
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Date of Event
    January 13, 2017
    Report Date
    March 14, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: MANUFACTURER CORRECTED TO TELEFLEX MEDICAL ATHLONE. THE SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER OF THE RETURNED SAMPLE (8VQABFSN) WAS DIFFERENT THAN WHAT WAS ORIGINALLY REPORTED BY THE CUSTOMER (8VNAQEKG). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOT NUMBER OF THE SAMPLE RECEIVED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE USAGE RECORD CARD THAT WAS RETURNED WITH THE SAMPLE LISTED 10 USES. THE INVOICE DATE OF THE DEVICE WAS JUNE 5, 2015, INDICATING THAT THE DEVICE HAS BEEN OUT OF WARRANTY SINCE JUNE 2016. A VISUAL EXAM WAS PERFORMED ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE DEVICE WAS YELLOWISH IN COLOR. AN ATTEMPT WAS MADE TO INFLATE THE DEVICE, HOWEVER, IT WAS UNABLE TO HOLD AIR. THE DEVICE WAS THEN IMMERSED INTO WATER AS IT WAS BEING INFLATED AND AIR BUBBLES WERE OBSERVED COMING FROM THE CUFF. UPON CLOSER EXAMINATION, IT WAS OBSERVED THAT THERE WAS A CUT/PUNCTURE ON THE SURFACE OF THE CUFF THAT MEASURED 2 MM. OTHER REMARKS: BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. IT WAS DETERMINED THAT THE CUFF WAS INADVERTENTLY CUT/PUNCTURED DURING HANDLING. THE IFU FOR THE PRODUCT STATES THAT LMA REUSABLES SHOULD BE HANDLED WITH CARE. PLACING, WASHING OR AUTOCLAVING WITH ITEMS WHICH HAVE HARD AND SHARP EDGE/POINTS SHOULD BE AVOIDED BECAUSE IT WILL HAVE ADVERSE IMPACT TO THE SILICONE MATERIAL OF THE CUFF AND WILL PERMANENTLY DAMAGE ITS PROPERTIES TO AN IRREPARABLE CONDITION. CUSTOMER IS ALSO REMINDED THAT LMA PROSEAL IS REUSABLE AND WARRANTED AGAINST MANUFACTURING DEFECTS FOR FORTY (40) USES OR A PERIOD OF ONE (1) YEAR FROM DATE OF PURCHASE (WHICHEVER IS THE EARLIER).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THS COMPLAINT HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT BEFORE INTUBATING THE DOCTOR FOUND THERE WAS A LEAK. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR DELAY INTREATMENT. FROM THE DESCRIPTION THE ALLEGED DEFECT WAS FOUND IN THE CLINICAL SETTING.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT BEFORE INTUBATING, THE DOCTOR FOUND THERE WAS A LEAK. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR DELAY INTREATMENT. FROM THE DESCRIPTION THE ALLEGED DEFECT WAS FOUND IN THE CLINICAL SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204558 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8VNAQEKG

    Patients

    Seq Age Sex Outcome Treatment
    1