BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT 4X4 HEMOSTATIC DRESSING

    MDR report key: 5042034 · Received August 31, 2015

    Report

    Report Number
    3004138549-2015-00001
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    June 3, 2015
    Report Date
    August 18, 2015
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FROM FDA DID NOT IDENTIFY THE CUSTOMER NAME, ADDRESS, PHONE NUMBER, OR PRODUCT LOT NUMBER. A FOLLOW UP EMAIL WAS SENT TO FDA WHO RESPONDED THAT THE REPORTER WISHED TO REMAIN ANONYMOUS. THEREFORE, NO FURTHER INFORMATION CAN BE OBTAINED FROM THE CUSTOMER ABOUT THE SITUATION. THE QUIKCLOT 4X4 HEMOSTATIC DRESSING LABELING CLEARLY STATES THAT THE "PRODUCT IS NOT ABSORBABLE AND MUST BE REMOVED FROM THE WOUND PRIOR TO WOUND CLOSURE". THE LABELING ALSO STATES THAT "THE QUIKCLOT HEMOSTATIC DRESSING MUST NOT REMAIN IN THE WOUND FOR LONGER THAN 24 HOURS". THE HEALTHCARE PROFESSIONAL ACKNOWLEDGED THAT THE "QUIKCLOT IS NON-ABSORBABLE AND SHOULD HAVE BEEN REMOVED WITHIN 24 HOURS BUT WAS OVERLOOKED". THE HEALTHCARE PROFESSIONAL SUGGESTED THAT ONLY LARGE FORMAT DRESSINGS SHOULD BE USED FOR PACKING. THE QUIKCLOT HEMOSTATIC DRESSINGS ARE OFFERED IN A VARIETY OF SHAPES AND SIZES INCLUDING 4 INCH X 4 INCH DRESSINGS, 3 INCH X 4 YARD ROLLS, 3 INCH X 4 YARD Z-FOLDED DRESSINGS, AND 3-PLY 12 INCH X 12 INCH TRAUMA PADS. USING THEIR CLINICAL JUDGEMENT, THE HEALTHCARE PROFESSIONAL MAY CHOOSE THE MOST APPROPRIATE DEPENDING ON THE PATIENT CONDITION, TYPE AND SIZE OF THE WOUND. HEALTHCARE FACILITIES TYPICALLY HAVE PROTOCOLS TO ACCOUNT FOR THE USE OF DRESSING WHEN THEY ARE APPLIED AND REMOVED TO ENSURE THAT NOTHING IS INADVERTENTLY LEFT INSIDE A PATIENT. THE HEALTHCARE PROFESSIONAL ALLEGES THAT THE X-RAY DETECTABLE THREAD MAY BE FAINTER OR THINNER THAN TRADITIONAL OPERATING ROOM SPONGES. HOWEVER, MILLIONS OF QUIKCLOT PRODUCTS HAVE BEEN DISTRIBUTED AROUND THE WORLD OVER THE PAST 8 YEARS WITH A HIGH DEGREE OF SUCCESS AND NO PROBLEMS WITH THE RADIOPAQUE THREAD USED. THE RADIOPAQUE THREAD USED IN QUIKCLOT HEMOSTATIC DRESSINGS HAS BEEN TESTED TO AND COMPLIES WITH ASTM F640-07 (STANDARD TEST METHODS FOR DETERMINING RADIOPACITY FOR MEDICAL USE). ADDITIONAL COMPARATIVE AND SIMULATED USE TESTING FOUND THE RADIOPAQUE THREAD USED IN QUIKCLOT PRODUCTS TO BE VISIBLE UNDER X-RAY. DEVICE NOT RETURNED / LOT# UNKNOWN.

    Description of Event or Problem · 1

    ON 8/4/2015 Z-MEDICA RECEIVED A LETTER FROM FDA (DATED 7/29/2015) WITH A VOLUNTARY MDR REPORT ATTACHED (REPORT# MW5043228). THE REPORT ALLEGES THAT AN EVENT OCCURRED ON (B)(6) 2015 INVOLVING QUIKCLOT 4X4 HEMOSTATIC DRESSING, PART# 459. THE REPORT SPECIFIES THAT A MALE PATIENT WAS PRESENTED TO A TRAUMA CENTER WITH A RIGHT CHEST STAB WOUND AND SUBCLAVIAN ARTERY TRANSECTION. THE QUIKCLOT 4X4 (PRODUCT# 459) WAS PACKED IN THE STAB WOUND AND THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR A STERNOTOMY AND ARTERIAL REPAIR. THE HEALTHCARE PROFESSIONAL ACKNOWLEDGED THAT QUIKCLOT IS NON-ABSORBABLE AND SHOULD HAVE BEEN REMOVED WITHIN 24 HOURS. THE HEALTHCARE PROFESSIONAL ALLEGES THAT DESPITE THE RADIO-OPAQUE MARKER IN QUIKCLOT DRESSING, THE PRESENCE OF DRESSINGS IN STAB WOUND WAS NOT IDENTIFIED IN SOME OF THE X-RAYS OR CT CHEST SCANS. POST-OPERATIVELY, THE WOUND HAD TO BE DRAINED DUE TO AN ABSCESS. THE DRESSING WAS FOUND AND REMOVED FROM THE INCISION SITE 73 DAYS AFTER INSERTION. THE HEALTHCARE PROFESSIONAL FELT THAT THE MARKER IS CONSIDERABLY FAINTER AND THINNER THAN RADIO-OPAQUE MARKERS USED IN TRADITIONAL GAUZE MAKING THE DRESSING MORE DIFFICULT TO IDENTIFY ON PLAIN RADIOGRAPH AND CT SCAN. IT WAS FURTHER RECOMMENDED BY THE HEALTHCARE PROFESSIONAL THAT A MORE VISIBLE RADIO-OPAQUE MARKER BE USED DUE TO THE RISK OF LEAVING THIS PRODUCT IN TRAUMATIC WOUNDS. THE HEALTHCARE PROFESSIONAL ALSO SUGGESTED THAT ONLY LARGE FORMAT DRESSING (SUCH AS ROLLS) SHOULD BE USED FOR PACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574545 QUIKCLOT 4X4 HEMOSTATIC DRESSING HEMOSTATIC DRESSING, NON-ABSORBABLE FRO Z-MEDICA, LLC 459 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other