BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIKCLOT INTERVENTIONAL,PRESLIT,MULTI-LANG,10X

    MDR report key: 21806168 · Received April 9, 2025

    Report

    Report Number
    3011137372-2025-00117
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 19, 2025
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    UDI-DI
    10841495150248
    PMA / PMN Number
    K120782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN #: (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED AT OUR MANUFACTURING SITE FOR EVALUATION. THERE ARE NO INDICATIONS THAT THE PRODUCT FAILED TO FUNCTION AS INTENDED. A REVIEW OF MANUFACTURING PROCESS REVEALED THAT THE COAT WEIGHTS RECORDED FOR THIS LOT OF DRESSING PADS HAD A 2.86 CPK WHICH INDICATES THE COATING PROCESS OF KAOLIN WAS WELL CONTROLLED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. AN ASSESSMENT OF THE REPORTED EVENT AND THE INSTRUCTIONS FOR USE (IFU) SUGGESTS THAT THE INSTRUCTIONS MAY NOT HAVE BEEN FOLLOWED AS SPECIFIED. THE IFU STATES: "APPLY FIRM, NON-OCCLUSIVE MANUAL COMPRESSION ON THE PAD FOR AT LEAST 5 MINUTES OR UNTIL BLEEDING/OOZING STOPS." BASED UPON THIS EVALUATION, UNINTENTIONAL USE ERROR (FAILURE TO FOLLOW IFU) LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "STAFF IN MICU WERE TRAILING/EVALUATING PRE-SLIT FOR CVC LINE BLEEDING/OOZING. AFTER INITIAL PLACEMENT OF GAUZE WAS SATURATED AND REPLACED AGAIN AND SAME OCCURRENCE AND REPLACED AGAIN. HEMOSTASIS WAS NOT ACHIEVED SO ALTERNATIVE ACTIONS TAKEN 3 FAILED ATTEMPTS. ACCORDING TO THE NM THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT." ASSOCIATED COMPLAINTS 3011137372-2025-00117, 3011137372-2025-00115 AND 3011137372-2025-00116.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "STAFF IN MICU WERE TRIALING/EVALUATING PRE-SLIT FOR CVC LINE BLEEDING/OOZING. AFTER INITIAL PLACEMENT OF GAUZE WAS SATURATED AND REPLACED AGAIN AND SAME OCCURRENCE AND REPLACED AGAIN. HEMOSTASIS WAS NOT ACHIEVED SO ALTERNATIVE ACTIONS TAKEN 3 FAILED ATTEMPTS. ACCORDING TO THE (B)(6) THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT." ASSOCIATED COMPLAINTS 3011137372-2025-00115 AND 3011137372-2025-00116.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665262 QUIKCLOT INTERVENTIONAL,PRESLIT,MULTI-LANG,10X DRESSING, WOUND, DRUG QSY Z-MEDICA, LLC 44F23J0019 10841495150248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED