BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL KIT

    MDR report key: 7446328 · Received April 19, 2018

    Report

    Report Number
    MW5076566
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 17, 2018
    Manufacturer
    PATH-TEC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A KIDNEY NEEDLE BIOPSY WAS RECEIVED IN A CONTAINER MISLABELED FROM MFR. WAS LABELED FOR IMMUNOFLUORESCENCE AND SHOULD HAVE CONTAINED ZEUS FIXATIVE, BUT ACTUALLY CONTAINED 10% NEUTRAL BUFFERED FORMALIN RENDERING THE SAMPLE UNUSABLE. LAB WAS UNABLE TO PERFORM THE REQUESTED TEST. FORTUNATELY THERE WERE KIDNEY GLOMERULI IN THE FORMALIN FIXED TISSUE, OTHERWISE, A RECOLLECT WOULD BE NECESSARY, REQUIRING PT TO UNDERGO ANOTHER PROCEDURE. WE CONTACTED THE MFR WHO WAS UNWILLING TO ISSUE A PRODUCT RECALL. WE RECEIVED ANOTHER SAMPLE THE VERY NEXT DAY WITH THE SAME LOT NUMBER PS18-16425 ((B)(6) MALE) THAT RENDERED ANOTHER SAMPLE UNUSABLE. AGAIN, MFR WAS NOTIFIED, BUT STILL UNWILLING TO ISSUE A RECALL.(B)(4). LOT NUMBER 2218010518. DATES OF USE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: EVALUATION OF KIDNEY BIOPSY. RENAL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286765 RENAL KIT BIOPSY INSTRUMENT KNW PATH-TEC 2218 2218010518
    286766 RENAL KIT BIOPSY INSTRUMENT KNW PATH-TEC 2218 2218010518

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other