BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE

    MDR report key: 12920798 · Received December 2, 2021

    Report

    Report Number
    8040412-2021-00300
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 7, 2021
    Report Date
    November 9, 2021
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED; HOWEVER, A PHOTO WAS PROVIDED BY THE CUSTOMER. THE MANUFACTURING SITE HAS REVIEWED THE PHOTO AND REPORTED THE FOLLOWING: "INVESTIGATION WAS CONDUCTED BY REFERRING THE PICTURE PROVIDED, SHOWED THE OVERALL LENGTH (OL) OF THE SAMPLE ARE VARIES FROM 100MM AND 105MM. THE OVERALL LENGTH (OL) FOR THE PRODUCT WITH CATALOG NUMBER 185420-000180 SHOULD BE 95MM 10 (85MM TO 110MM) BASED ON THE TECHNICAL DRAWING U933 000 TD. THEREFORE, THE OVERALL LENGTH (OL) STILL IN SPECIFICATION." "PLUS, THIS PRODUCT HAS ADJUSTABLE FLANGE , HENCE THE LENGTH CAN BE ADJUSTED ACCORDINGLY. MOREOVER, THERE WAS NO POUCH OR INNER BOX RETURNED FOR PRODUCT LABEL EVALUATION AND FURTHER INVESTIGATION. DUE TO LIMITED INFORMATION PROVIDED, IT IS DIFFICULT TO TRACE AND TO IDENTIFY IF THE PRODUCT WAS WRONG. IN OUR MANUFACTURING PROCESS, ALL PRODUCTS WILL UNDERGO 100% INSPECTION PRIOR TO PRODUCT SPECIFICATION FOR EXAMPLE OVERALL LENGTH. ANY DEFECTIVE OR OUT OF SPECIFICATION WILL BE SCRAP DURING THIS PROCESS. UPON COMPLETED INSPECTION PROCESS, THE PRODUCT WILL UNDERGO QA INSPECTION PER AQL SAMPLING PLAN."

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED "THE CHILD'S PARENTS REPORTED DISCREPANCIES WITH REGARDS TO SIZE AND LENGTHS OF THE ROUNDED TIPS FOR THE 185420-000180. IT WAS NOTED FOR DIFFERENT LOT NUMBERS (LOT NUMBERS UNKNOWN)". NO SERIOUS INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "THE CHILD'S PARENTS REPORTED DISCREPANCIES WITH REGARDS TO SIZE AND LENGTHS OF THE ROUNDED TIPS FOR THE 185420-000180. IT WAS NOTED FOR DIFFERENT LOT NUMBERS (LOT NUMBERS UNKNOWN)". NO SERIOUS INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819272 RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE AIRWAY, NASAL BTQ TELEFLEX MEDICAL SDN. BHD. IPN042903 KMA21F0424

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Female