BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PE ADULT-PED WET LF 6/CS

    MDR report key: 9474220 · Received December 16, 2019

    Report

    Report Number
    3004365956-2019-00371
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 21, 2019
    Report Date
    December 9, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). DHR REVIEW WAS PERFORMED AND DOCUMENTED ON THE PREVIOUS COMPLAINT REPORT WITH NO FINDINGS. (B)(4) SAMPLE OF CODE A-8000-08LF WAS RECEIVED FOR ANALYSIS. SAMPLE WAS RECEIVED ON ITS ORIGINAL HEADER BAG PACKAGE. SAMPLE DOES NOT SHOW SIGNS OF PATIENT USE SINCE THE ORIGINAL PACKAGING REMAINS UNOPENED. A LABEL NUMBER LBL000918 R03 WHICH SHOWS THE PART NUMBER A-8000-08LF AND BATCH NUMBER 74G1800477 WAS OBSERVED ON THE SAMPLE. DURING VISUAL INSPECTION IT WAS OBSERVED A HOLE ON THE HEADER BAG INDICATED BY A MARKER BY THE CUSTOMER. ALSO, 3 STAPLES WERE OBSERVED AROUND THE HEADER BAG. NO OTHER ISSUES WERE FOUND. DURING VISUAL INSPECTION, IT WAS OBSERVED A HOLE ON THE HEADER BAG INDICATED BY A MARKER BY THE CUSTOMER. THIS HOLE HAS SIGNS THAT BE CAUSED BY A HIT DURING THE UNIT FALLEN WITH THE CORNER OF IT. ALSO, 3 STAPLES WERE OBSERVED AROUND THE HEADER BAG. THE STAPLE LOCATED ON THE UPPER RIGHT CORNER WAS APPLIED INSIDE THE SEAL OF THE UNIT. STAPLES USE IT IS NOT PART OF ASSEMBLY PROCESS OF FG A-8000-08LF. HOWEVER, IT IS UNKNOWN HOW SUCH HOLE GOT PRODUCED ON THE SAMPLE. CURRENT PACKAGING PROCESS WERE AUDIT ON THE ASSEMBLY LINE, AND IT WAS OBSERVED THAT EACH UNIT BEING PACKAGED AS PER WI-PEV-034 R24 (SEE LAST SLIDE OF THE ATTACHED PRESENTATION) WITH ENOUGH CONTROLS IN THE MANUFACTURING ASSEMBLY PROCESS THAT CAN DETECT THIS CONDITION PRIOR SHIP THE MATERIAL. ADDITIONALLY, NO DAMAGE WAS REPORTED IN THE DC NOR STERILIZER FOR THE LOT IN QUESTION. ALTHOUGH DAMAGE ON THE HEADER BAG OF THE PRODUCT 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. THE HOLE OBSERVED ON THE SAMPLE COULD ONLY HAPPEN BY A LARGE-HIT, WHICH INDICATES THAT THE PRODUCT WAS HIT WITH AN OBJECT SOMEWHERE ON THE DISTRIBUTION CHAIN OUTSIDE OF THE MANUFACTURING FACILITY CONTROL SINCE THERE IS NO INTERNAL NC NOR RECORDS THAT SHOWS THAT THIS PRODUCT SUFFER , ANY DAMAGE DURING ITS MANUFACTURE. HOWEVER, THE PERSONNEL OF THE ASSEMBLY LINE WERE NOTIFIED ON (B)(6)2020 FOR AWARENESS.

    Description of Event or Problem · 0

    THE REPORT STATES THAT THERE IS A HOLE IN THE PACKAGING WHICH COMPROMISED THE STERILITY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE REPORT STATES THAT THERE IS A HOLE IN THE PACKAGING WHICH COMPROMISED THE STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268743 PE ADULT-PED WET LF 6/CS BOTTLE, COLLECTION, VACUUM KDQ TELEFLEX MEDICAL 74G1800477

    Patients

    Seq Age Sex Outcome Treatment
    1