BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD HAND DRAPE 114 IN. X 142 IN. 289 CM X 360 CM

    MDR report key: 21721573 · Received March 28, 2025

    Report

    Report Number
    3014421917-2025-00010
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Report Date
    April 28, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651132278
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER OF THE HALYARD HAND DRAPE 114 IN. X 142 IN. / 289 CM X 360 CM - HANDI-BIN. THE COMPLAINT HAND DRAPE IS CONTRACT MANUFACTURED BY LIANYUNGANG AIYEH NON-WOVEN PRODUCTS CO., LTD. (FDA REGISTRATION NUMBER (B)(4)). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON MARCH 7, 2025. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE MANUFACTURER. 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE AVAILABLE FOR EVALUATION. DEVICE HISTORY RECORDS FOR TWO COMPLAINT LOTS WERE REVIEWED. NO ISSUES WERE DOCUMENTED IN THE PRODUCTION RECORDS, NO SIMILAR DEFECTS WERE DETECTED THROUGH INSPECTION PROCESSES. NO DEVIATIONS WERE REPORTED DURING MANUFACTURE. PROCESS EVALUATION FOUND THAT FRICTION LIKELY CAUSED REINFORCEMENT PIECE TO FLUFF. THIS IS THE SECOND COMPLAINT FOR FABRIC LINTING FROM JAN 2024 TO MAR 2025, THE CPM (COMPLAINTS PER MILLION) IS (B)(4). THERE IS NO NEGATIVE TREND FOR THIS ISSUE FOR THE COMPLAINT PRODUCT. ASSEMBLY OPERATORS HAVE BEEN NOTIFIED. OPERATORS WILL CLEAN THE NON-WOVEN FABRIC CUT PIECES TO PREVENT THE GENERATION OF DEBRIS. OPERATORS HAVE BEEN RETRAINED. 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 THERE IS LINTING IN THE CONTROL PLUS AREA OF THE DRAPE. PER THE CUSTOMER, THE STAFF WAS HAVING TO CLEAN INSTRUMENTS CAREFULLY TO ENSURE "FLUFF" DID NOT COME INTO THE SURGICAL WOUND. THERE WAS 10-20 MINUTE DELAY DURING PROCEDURE DUE TO HAVING TO ENSURE DEBRIS REMOVAL. NO LINT WENT INTO THE PATIENT'S WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698772 HALYARD HAND DRAPE 114 IN. X 142 IN. 289 CM X 360 CM SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 13227 CA24082XXX, CA24064XXX 30680651132278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown