BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP

    MDR report key: 25304217 · Received May 27, 2026

    Report

    Report Number
    1054380-2026-00005
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341830
    PMA / PMN Number
    K234050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS RECEIVED WITH A CIRCLED AREA IDENTIFYING THE REPORTED DEFECT LOCATION, WHICH APPEARED TO BE A CLEAN-EDGED SLIT. THE SLIT PENETRATED BOTH LAYERS AND ALIGNED ACROSS EACH LAYER. BASED ON TRACKING AND TRENDING DATA, THE MOVING AVERAGE FOR THIS DEFECT ISSUE IS APPROXIMATELY 0.9 CPM (COMPLAINTS PER MILLION), WITH NO NEGATIVE TREND IDENTIFIED OVER THE PAST 12 MONTHS. A ROOT CAUSE FOR THIS SPECIFIC INCIDENT COULD NOT BE DETERMINED WITHIN OUR MANUFACTURING PROCESS. THE SAMPLE WAS RECEIVED IN A POST-STERILIZED CONDITION, AND DETAILS REGARDING THE STERILIZATION PROCESS AND ASSOCIATED CONDITIONS WERE NOT AVAILABLE FOR EVALUATION. MANUFACTURING PROCESS CONTROLS AND PRODUCT TESTING RESULTS ARE ROUTINELY MONITORED AND USED TO SUPPORT CONTINUOUS QUALITY IMPROVEMENT ACTIVITIES. CUSTOMER FEEDBACK IS REVIEWED BY THE COMPLAINT REVIEW BOARD, WHICH UTILIZES METRICS SUCH AS CPM (COMPLAINTS PER MILLION) AND STATISTICAL TREND ANALYSIS TO EVALUATE PROCESS EFFECTIVENESS AND QUALITY PERFORMANCE. THIS INCIDENT WILL BE INCORPORATED INTO ONGOING COMPLAINT TRENDING AND REVIEW ACTIVITIES TO SUPPORT IDENTIFICATION OF ANY EMERGING PATTERNS. NO ADDITIONAL CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME, A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE MATERIAL MET ESTABLISHED SPECIFICATION REQUIREMENTS. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HOLES WERE IDENTIFIED IN THE PRODUCT AFTER STERILIZATION IN THE OPERATING ROOM, RESULTING IN A DELAY OF THE PROCEDURE. THE SURGERY WAS NOT CANCELED; HOWEVER, A BREACH OF THE STERILE BARRIER WAS NOTED. INFORMATION WAS RECEIVED ON MARCH 31, 2026, STATING THERE WAS HOLE IN THE WRAP DISCOVERED WHEN OPENING THE BOX. A QUESTIONNAIRE WAS SENT TO THE REPORTER WHO REPLIED ON (B)(6) 2026 WITH FURTHER DETAILS INDICATING THIS WAS DISCOVERED IN THE OPERATING ROOM AND THERE WAS A BREACH IN STERILITY AT WHICH POINT THE NEW DETAILS LED TO CONCLUSION THIS WAS A REPORTABLE MALFUNCTION DUE TO INCREASED LIKELIHOOD THAT RECURRENCE MAY LEAD TO A SERIOUS INJURY OR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198514 KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP STERILIZATIONS PRODUCTS FRG O&M HALYARD, INC. 34183 LR5078 30680651341830

    Patients

    Seq Age Sex Outcome Treatment
    1