BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC HEMOSTATIC DRESSING, 2X2, 10X

    MDR report key: 21095551 · Received January 7, 2025

    Report

    Report Number
    3004138549-2025-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 13, 2024
    Report Date
    December 18, 2024
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    PMA / PMN Number
    K123387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINANT SUPPLIED PHOTOS OF THE CLAIMED "X-RAY STRIP FELL OFF" THE PRODUCT. X-RAY THREAD FOR THIS PRODUCT IS APPROXIMATELY 3MM X 90MM. SUPPLIED PHOTOS SHOW AN OBJECT AT THE TIP OF A FORCEPS APPROXIMATELY 1MM IN LENGTH, POSSIBLY PART OF AN X-RAY THREAD. ADDITIONAL PHOTO SHOW GAUZE EDGES WHICH DO NOT APPEAR MAINTAIN A PRODUCT EDGE WHICH IS CREATED DURING THE MANUFACTURING PROCESS. THE PHOTOS SHOW EVIDENCE THE GAUZE HAD BEEN CUT OR TORN WHILE OUTSIDE Z-MEDICA CONTROL, THIS IS EVIDENT BY STRANDS OF MATERIAL PROTRUDING FROM THE GAUZE EDGE AS SEEN IN THE CUSTOMER PROVIDED PHOTOS. THE GAUZE IS DESIGNED TO BE USED IN THE CONFIGURATION WHICH IT WAS PRODUCED. TO ACCOMMODATE FOR DIFFERENT NEEDS THERE ARE SEVERAL DIFFERENT SIZES AVAILABLE. BASED ON THE PRODUCTION TESTING RESULTS AND THE SUPPLIED PHOTOS, IT IS THE OPINION THIS COMPLAINT (RESIDUAL STAND FROM THE X-RAY THREAD) WAS THE RESULT OF PRODUCT MODIFICATIONS AFTER THE PRODUCT HAD LEFT Z-MEDICA/TELEFLEX CONTROL. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING SURGERY, THE X-RAY STRIP FELL OFF THE GAUZE AND REMAINED INSIDE THE PATIENT'S BODY, CAUSING INCONVENIENCE IN REMOVING IT". ADDITIONAL INFORMATION RECEIVED STATES THAT "THERE WAS NO PATIENT HARM. THE ANESTHESIA TIME WAS EXTENDED, BUT IT WAS NOT CRITICAL. THE STRIP WAS REMOVED USING FORCEPS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING SURGERY, THE X-RAY STRIP FELL OFF THE GAUZE AND REMAINED INSIDE THE PATIENT'S BODY, CAUSING INCONVENIENCE IN REMOVING IT". ADDITIONAL INFORMATION RECEIVED STATES THAT "THERE WAS NO PATIENT HARM. THE ANESTHESIA TIME WAS EXTENDED, BUT IT WAS NOT CRITICAL. THE STRIP WAS REMOVED USING FORCEPS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882642 QC HEMOSTATIC DRESSING, 2X2, 10X DRESSING, WOUND, DRUG QSY Z-MEDICA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.