BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PE ADULT-PED DRY/ WET LF 6/CS

    MDR report key: 8838788 · Received July 29, 2019

    Report

    Report Number
    3004365956-2019-00197
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 2, 2019
    Report Date
    July 8, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DHR REVIEW WAS PERFORMED AND DOCUMENTED ON THE PREVIOUS COMPLAINT REPORT WITH NO FINDINGS. ONE SAMPLE WAS RECEIVED FOR ANALYSIS. SAMPLE WAS RECEIVED ON ITS ORIGINAL HEADER BAG PACKAGE. SUCH BAG WAS ALREADY OPENED BY THE CUSTOMER, BUT THE BOTTLE DOES NOT SHOW SIGNS OF PATIENT USE. IT WAS OBSERVED THAT THE WATER BOTTLE # 156292 WAS EMPTY AND WITH SMALL HOLE ON IT. A LABEL NUMBER LBL005396 R01 WHICH SHOWS THE PART NUMBER A-6000-08LF AND BATCH NUMBER 74K1800536 WAS OBSERVED ON THE SAMPLE. SOME OF THE COMPONENTS WERE MISSING SUCH AS THE BLUE WRAP (# 160536 PE ARJO WRAP 40"X40") & THE WHITE TRAY (# 160287 PE TRAY A-6000/A-9250). DURING VISUAL INSPECTION IT WAS NOTED THAT THE UNIT A-6000-08LF HAD SIGNS THAT THE WATER BOTTLE WAS PLACED PROPERLY ON THE UNIT DUE THE TAPE WAS FOUND ON THE UNIT. NO OTHER ISSUES WERE FOUND. DURING VISUAL INSPECTION, THE WATER BOTTLE # 156292 WAS FOUND EMPTY AND WITH A SMALL HOLE ON IT. HOWEVER, IT IS UNKNOWN HOW THAT DAMAGE GOT PRODUCED ON THE WATER BOTTLE SINCE THE PACKAGING PROCESS WERE AUDIT ON THE ASSEMBLY LINE AND IT WAS OBSERVED THAT EACH UNIT BEING PACKAGED AS PER WI-PEV-045 R37 (SEE LAST SLIDES OF THE ATTACHED PRESENTATION) WITH ENOUGH CONTROLS IN THE MANUFACTURING ASSEMBLY PROCESS THAT CAN DETECT THIS CONDITION PRIOR SHIPPING THE MATERIAL. NO DAMAGE REPORT WAS RECEIVED ON THE STERILIZER AND/OR SHIPPING OF THE INVOLVED BATCH 74K1800536 TO TELEFLEX NADC (NORTH AMERICA DISTRIBUTION CENTER). THE ROOT CAUSE FOR THE CONDITION REPORTED COULD NOT BE IDENTIFIED. ALTHOUGH DAMAGE ON THE WATER BOTTLE WAS CONFIRMED BASED ON VISUAL INSPECTION PERFORMED TO THE SAMPLE PROVIDED, IT IS NOT LIKELY THAT THE DAMAGES WERE ORIGINATED DURING THE MANUFACTURING ASSEMBLY, THEREFORE CUSTOMER COMPLAINT CANNOT BE CONFIRMED AS MANUFACTURED RELATED. IN ADDITION: NO DAMAGES WERE REPORTED FOR LOT 74K1800536 WHEN SENT FOR STERILIZATION AND NADC (NORTH AMERICA DISTRIBUTION CENTER). HOWEVER, THE PERSONNEL OF THE ASSEMBLY LINE WERE NOTIFIED ON (B)(6)2019 FOR AWARENESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN WE OPENED THE PACKAGING IN THE PATIENT'S ROOM THE STERILE WATER CONTAINER WAS DAMAGED AND LEAKING. CLINICAL CONSEQUENCES NOTED AS WASTE OF TIME FOR A STAFF THAT WAS ALL DRESSED IN STERILE OUTFIT AND WE ASKED OTHER STAFF TO GET ANOTHER DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD OF THE PRODUCT A-6000-08LF, BATCH NUMBER 74K1800536 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NONCONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. ALL MATERIALS USED DURING THE ASSEMBLY MET CURRENT SPECIFICATIONS. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN WE OPENED THE PACKAGING IN THE PATIENT'S ROOM THE STERILE WATER CONTAINER WAS DAMAGED AND LEAKING. CLINICAL CONSEQUENCES NOTED AS WASTE OF TIME FOR A STAFF THAT WAS ALL DRESSED IN STERILE OUTFIT AND WE ASKED OTHER STAFF TO GET ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633002 PE ADULT-PED DRY/ WET LF 6/CS BOTTLE, COLLECTION, VACUUM KDQ TELEFLEX MEDICAL 74K1800536

    Patients

    Seq Age Sex Outcome Treatment
    1