BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PE DRY/WET DUAL COLL LF 6/CS

    MDR report key: 14647845 · Received June 9, 2022

    Report

    Report Number
    3004365956-2022-00037
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 26, 2022
    Report Date
    May 26, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBER 74B2200767 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    QN#1 (B)(4). THE LOT NUMBER REPORTED 74B2200767 BELONGS TO MATERIAL A-6000-08LF. THE DEVICE HISTORY RECORD OF BATCH NUMBER 074B2200767 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED & INSPECTED ACCORDING TO OUR SPECIFICATIONS. ONE PHOTO OF COMPLAINT (B)(4) WAS RECEIVED FOR ANALYSIS. IN SUCH PHOTO IT WAS OBSERVED A CORNER OF ONE PLEUR EVAC UNIT WITH WRAP, A HEADER-BAG (P/N TFX-000255) AND A PART OF QUICK REFERENCE (P/N L02826). IN THE HEADER-BAG TFX-000255 IT WAS OBSERVED A DAMAGE ON IT LIKE AN ABRASION. IT WAS REVIEWED THE INCOMING INSPECTION RECORDS FOR COMPONENT TFX-000255 LOT 1855150 AND NO ISSUES WERE FOUND. THIS LOT WAS USED ON MANUFACTURING OF LOT 74B2200767 OF FG A-6000-08LF. THE NON-CONFORMANCES RECORDS OF 2022 FOR PLEUR EVAC CODES WERE REVIEWED AND IT WAS NOT FOUND NCS THAT CAN BE RELATED WITH THE ISSUE REPORTED IN THIS COMPLAINT. A "PUNCTURE HOLE ON THE PLASTIC PACKAGING" WAS NOT OBSERVED ON PHOTO RECEIVED FOR ANALYSIS, BUT A DAMAGE LIKE AN ABRASION IS APPRECIATED ON HEADERBAG TFX-000255. HOWEVER, IT CANNOT CONFIRM THAT SUCH DAMAGE WAS ORIGINATED DURING THE MANUFACTURE OF THE FG NOR CAUSED BY THE SUPPLIER OF THE COMPONENT TFX-000255 SINCE THIS IS SUPPLY BY AN EXTERNAL VENDOR. IT IS UNKNOWN IN WHAT PART OF SUPPLY CHAIN THE HEADERBAG P/N TFX-000255 WAS DAMAGED. NEVERTHELESS, THE COMPLAINTS AND NON-CONFORMANCES OF THIS TYPE WILL CONTINUE TO BE MONITORED VIA PERIODIC REVIEWS TO EVALUATE IF ANY TREND EXISTS.

    Description of Event or Problem · 0

    THERE IS A PUNCTURE HOLE ON THE PLASTIC PACKAGING THAT THE DRAIN COMES IN.

    Description of Event or Problem · 0

    THERE IS A PUNCTURE HOLE ON THE PLASTIC PACKAGING THAT THE DRAIN COMES IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218560 PE DRY/WET DUAL COLL LF 6/CS BOTTLE, COLLECTION, VACUUM KDQ TELEFLEX MEDICAL 74B2200767

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.