BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 601 SW,650 ML,JAPAN

    MDR report key: 5357221 · Received January 11, 2016

    Report

    Report Number
    1417411-2016-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    December 22, 2015
    Report Date
    December 25, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW OF MANUFACTURING EVENT LOG SHOWS NO ISSUES THAT MAY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. THE ROOT CAUSE IS UNKNOWN. THE COMPLAINT CANNOT BE CONFIRMED. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO A PINHOLE ON THE UPPER PART OF THE BOTTLE DURING USE OF WATER BOTTLE PRODUCTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE WATER BOTTLE WAS WITHOUT A HUMIDIFIER ADAPTOR. THE CUSTOMER MARKED THE BOTTLE TO SHOW THE LOCATION OF THREE (3) PIN HOLES ON THE SIDE OF THE BOTTLE. TO EVALUATE THE SAMPLE, THE BOTTLE WAS FILLED WITH APPROXIMATELY 650 ML OF STERILE WATER AND CONNECTED TO THE 011 TEST FIXTURE. AIR PRESSURE WAS APPLIED TO THE BOTTLE AND THE BOTTLE WAS OBSERVED FOR PINHOLE LEAKS. WATER WAS OBSERVED COMING FROM THE SITES INDICATED BY THE CUSTOMER, AND ALSO TWO OTHER SITES. SITE ENGINEERING EVALUATED THE COMPLAINT SAMPLE. SITE ENGINEERING DETERMINED THAT THE DEFECT WAS NOT RELATED TO THE MANUFACTURING PROCESS. QUALITY ASSURANCE PERFORMED A FURTHER VISUAL INSPECTION OF THE PIN HOLES. THE TOP OF THE BOTTLE WAS CUT OFF TO INSPECT THE PIN HOLES. THE INSPECTION SHOWED AN INDENTATION ON THE OUTSIDE WALL OF THE BOTTLE WHERE THE PIN HOLES WERE LOCATED AND THE INSIDE WALL OF THE BOTTLE SHOWED AN OUTWARD PROJECTION OF PLASTIC WHICH INDICATES THE PIN HOLES WERE MADE BY PRESSURE FROM THE OUTSIDE SURFACE OF THE BOTTLE. THE ENTIRE LOT (020156) OF PRODUCT WAS SHIPPED TO TELEFLEX (B)(4). THE SHIPMENTS ARRIVED IN (B)(6) OVER TWO MONTHS ((B)(6) 2015 TO (B)(6) 2015). (CON'T) OTHER REMARKS: TELEFLEX (B)(4) PERFORMS A 100% VISUAL INSPECTION OF ALL WATER PRODUCTS BEFORE BEING SHIPPED TO THEIR CUSTOMERS. THE INSPECTION REPORT DID NOT IDENTIFY ANY DEFECTS FOR PIN HOLES. THE COMPLAINT IS CONFIRMED; HOWEVER, AN EVALUATION OF THE MANUFACTURING PROCESS DETERMINED THIS DEFECT IS NOT RELATED TO THE TELEFLEX MANUFACTURING PROCESS. IN ADDITION, THE PRODUCT WAS SHIPPED TO TELEFLEX (B)(4), WHERE A 100% INSPECTION WAS PERFORMED ON THIS LOT. THE INVESTIGATION CONCLUDES THAT THE DEFECT OCCURRED AFTER THE PRODUCT WAS SHIPPED FROM TELEFLEX (B)(4). A CONCLUSION CODE COULD NOT BE CHOSEN AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT A PINHOLE WAS FOUND ON THE UPPER PART OF THE BOTTLE DURING USE. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT A PINHOLE WAS FOUND ON THE UPPER PART OF THE BOTTLE DURING USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15711 HUDSON AQUAPAK 601 SW,650 ML,JAPAN RESPIRATORY GAS HUMIDIFIER BTT TELEFLEX MEDICAL 020156

    Patients

    Seq Age Sex Outcome Treatment
    1