BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC HEMOSTATIC DRESSING, 4X4, 10X

    MDR report key: 12688433 · Received October 25, 2021

    Report

    Report Number
    3011137372-2021-00287
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 10, 2021
    Report Date
    September 29, 2021
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). DEVICE MASTER RECORD (DMR) FOR FINISHED GOOD 459 REV. J WAS REVIEWED AND THE BILL OF MATERIAL (BOM) CONTAINS THE REQUIREMENT OF ADDING ONE IFU 101282-01. PER CARTON (10X) WHICH IS THE SELLABLE UNIT. DESIGN FMEA FOR QUIKCLOT HEMOSTATIC DRESSINGS REV. DATE: 01/06/2021 WAS REVIEWED AND RISKIDS #47 THRU #49 HAS THE RISK IDENTIFIED WHEN GAUZE STAYS LONGER THAN 24 HOURS WHICH CAN LEAD TO THE GAUZE RETAINED IN PATIENT'S BODY. SINCE PATIENT CONDITION WAS NOT CONFIRMED BY THE PHYSICIAN, WORST CASE SCENARIO WILL BE CONSIDERED. N CASE OF RE-OPERATION AND/OR INFECTION THE CORRESPONDING SEVERITY SCORE IS 4 AND OCCURRENCE IS 2. CONTROLS TO MITIGATE THIS RISK ARE ASSOCIATED TO THE IFU CONTENT TO PROVIDE APPLICABLE WARNINGS AND HCP TRAINING. IFU P/N 101282-01 REQUIRED FOR P/N 459 PACKAGING PROCESS WAS REVIEWED FROM REVISION D (03/27/2017) THRU REVISION F (11/04/2020 - LATEST VERSION OF THE IFU), AND THE IFU CONTAINS THE WARNING DISCLOSING THAT THE PRODUCT IS NOT ABSORBABLE AND MUST BE REMOVED FROM THE WOUND PRIOR TO WOUND CLOSURE. IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED TO AN INTENTIONAL USER ERROR (MISUSE) OF CUTTING THE DEVICE WHICH MAY HAVE CONTRIBUTED TO LEAVING THE GAUZE INSIDE THE PATIENT. THE PRODUCT CONTAINS THE APPLICABLE WARNINGS TO ENSURE GAUZE IS NOT GOING TO BE LEFT INSIDE THE WOUND AFTER COMPLETING THE CLINICAL PROCEDURE. IN ADDITION, GAUZE APPLICATION PROCEDURE NOT FOLLOWED BY RESIDENT AS ESTABLISHED IN THE IFU P/N 101282-01 REV. F. FURTHERMORE, AS PART OF THE INFORMATION THE PHYSICIAN HIGHLIGHTED THAT EDUCATIONAL ACTIVITIES WERE NOT DEEMED NECESSARY AT THIS POINT FROM THEIR BEHALF. MANUFACTURING RELATED EVENT CAN BE DISMISSED SINCE NO REPORT WAS INCLUDED IN THIS COMPLAINT DESCRIPTION REGARDING MISSING IFU NOR MISSING CONTENT TO SUPPORT THE USE OF THE DEVICE. NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS POINT. IFU P/N 101812-01 REV. F CONTAINS APPROPRIATE INSTRUCTIONS REGARDING APPROPRIATE APPLICATION AND REMOVAL OF THE GAUZE. COMPLAINT WAS CONFIRMED AS MISUSE OF THE DEVICE. CONFIRMATION WAS COMPLETED THROUGH IFU AND DMR REVIEW. APPLICABLE WARNINGS ARE PRESENT IN THE DEVICE IFU TO ENSURE PROPER USE OF THE DEVICE. NO ADDITIONAL ACTIONS WERE DEEMED NECESSARY DUE TO THE NATURE OF THE NON-CONFORMANCE. REVIEWED DOCUMENTS ARE ATTACHED TO THIS INVESTIGATION. A NOTIFICATION WILL BE SENT TO THE PHYSICIAN TO HIGHLIGHT THE IMPLICATIONS AND RISKS OF MISUSE OF THE DEVICE AND REINFORCEMENT TO FO LLOW PROVIDED IFU INSTRUCTIONS OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    NOTE ON OR DESK WINDOW SHOWING NO MORE QUIKCLOT TO BE IN THE OR. PRODUCT 459 AS IT IS THE ONLY QUICKCLOT PRODUCT THEY HAVE USED. WE BELIEVE THIS HAPPENED WITHIN THE LAST COUPLE MONTHS. WHEN WE MET WITH THE PHYSICIAN LAST WEEK SHE WAS VERY VAGUE IN WHAT HAPPENED. OUR ASSUMPTION IS A RESIDENT TRIMMED THE 4X4 AND LEFT IT IN A PATIENT AND MY GUESS THIS HAS BEEN HOW THEY HAVE USED THE PRODUCT FOR QUITE SOME TIME.

    Description of Event or Problem · 0

    NOTE ON OR DESK WINDOW SHOWING NO MORE QUIKCLOT TO BE IN THE OR. PRODUCT 459 AS IT IS THE ONLY QUICKCLOT PRODUCT THEY HAVE USED. WE BELIEVE THIS HAPPENED WITHIN THE LAST COUPLE MONTHS. WHEN WE MET WITH THE PHYSICIAN LAST WEEK SHE WAS VERY VAGUE IN WHAT HAPPENED. OUR ASSUMPTION IS A RESIDENT TRIMMED THE 4X4 AND LEFT IT IN A PATIENT AND MY GUESS THIS HAS BEEN HOW THEY HAVE USED THE PRODUCT FOR QUITE SOME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592300 QC HEMOSTATIC DRESSING, 4X4, 10X FRO Z-MEDICA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown