BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY TUBE INNER CANULA (TTIC), HVLP CU

    MDR report key: 4961414 · Received July 29, 2015

    Report

    Report Number
    9611710-2015-00138
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 28, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A QUALITY INVESTIGATION WAS ALSO PERFORMED ON (B)(6) 2015 FOR THE RETURNED PRODUCT. THE RETURNED PRODUCTS WERE CLOSELY EXAMINED. AN ANALYSIS ON THE RETURNED SAMPLES PROVIDED WERE INSPECTED AND DID NOT PERFORM TO OUR REQUIREMENT. OUT OF THE (B)(4) UNITS RETURNED, (B)(4) UNITS WERE CONFIRMED THAT THE INNER CANNULA WHITE HAD THE WRONG SIZE; MARKED WITH ID (B)(4) MM BUT THE INNER CANNULA IS MARKED WITH THE ID (B)(4) MM, WHICH DOES NOT CORRESPOND TO SIZE (B)(4) MM PRODUCT. THIS WARRANTS FURTHER ACTION AND A NON-CONFORMANCE. AN EVENT WILL BE OPENED AND THIS COMPLAINT WILL REMAIN OPEN UNTIL THE COMPLETION OF THE NON-CONFORMANCE. A BATCH REVIEW WAS PERFORMED AND YIELDED NO DEFICIENCIES DURING THE SEALING AND INSPECTION. THERE WAS NOT POTENTIAL OF MIXED SIZE AS THE LOT RETRIEVED FOUND NO (B)(4) MM AS ALLOCATED TOGETHER. REVIEW OF THE INCOMING RAW MATERIAL DID NOT REVEAL SIZE (B)(4) MM OF INNER CANNULA RECEIVED WITHIN THE SAME PERIOD OF TIME. CORRECTION DUE TO THE INITIAL MDR SUBMITTED JULY 30, 2015, MFR# 9611710-2015-00138 DID NOT CONTAIN THE FOLLOWING: FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2015 STATING "OUR DISTRIBUTOR REPORTED (B)(4) DEFECTIVE DEVICES." THESE COMPLAINTS CONCERNING THE TRACHEOSTOMY TUBE WITH HVLP CUFF AND INNER CANNULA, (B)(4) ICC PRODUCT CODE/REFERENCE # (B)(4), LOT # 543443R001. ALL HAVE THE SAME ISSUE, "INNER CANNULA GETS IN OUR CANNULA TOO TIGHTLY." NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. ADDITIONAL PATIENT / EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRACHEOSTOMY PROCEDURE, THE INNER CANNULA COULD ONLY BE INSERTED HALF WAY INTO THE OUT CANNULA ANE THEN IT BECAME BLOCKED. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER PRODUCT WAS PLACED. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THE PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492552 TRACHEOSTOMY TUBE INNER CANULA (TTIC), HVLP CU TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD R72721070 54344R001

    Patients

    Seq Age Sex Outcome Treatment
    1