BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD* POLYISOPRENE/NEOPRENE HYBRID POWDER-FREE STERILE SURGICAL GLOVES

    MDR report key: 17419171 · Received July 28, 2023

    Report

    Report Number
    3014421917-2023-00010
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    June 28, 2023
    Report Date
    October 17, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    KGO
    UDI-DI
    30680651483301
    PMA / PMN Number
    K151694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THE COMPLAINT PRODUCT WAS MANUFACTURED BY ANSELL (FDA REGISTRATION: 8041180). O&M HALYARD, INC. SUBMITTED INITIAL MDR IN ERROR. O&M HALYARD, INC. IS THE INITIAL IMPORTER OF DEVICE; HOWEVER, THERE WAS NO SERIOUS INJURY OR ILLNESS (ADVERSE EVENT) ASSOCIATED WITH THIS COMPLAINT THEREFORE PURSUANT TO 21 CFR 803 A REPORT TO FDA IS NOT REQUIRED BY THE INITIAL IMPORTER. THE MANUFACTURER DID RESPOND TO SUPPLIER CORRECTIVE ACTION REQUEST WITH INVESTIGATION FINDINGS. NO SAMPLES WERE PROVIDED BY THE CUSTOMER. THE RETAINED SAMPLES WERE REVIEWED. NO ABNORMALITIES WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, NO ISSUES WERE FOUND. THE PRODUCT INSPECTIONS WERE CONFORMING WITH NO NOTED ISSUES. THERE WAS NO STOCK OF THE FINISHED GOOD AVAILABLE AT TIME OF INVESTIGATION. THE MANUFACTURER WAS UNABLE TO DEFINE A ROOT CAUSE. THEY DID PERFORM A VALIDATION IN JANUARY OF 2023 TO IMPROVE THE HOMOGENEITY OF THE COAGULANT APPLICATION. THE MANUFACTURING SITE WILL CONTINUE TO MONITOR THE DEFECTS PER MILLION FOR PERIOD FEBRUARY 2023 - NOVEMBER 2023 TO ENSURE NO COMPLAINT TRENDS ARE NOTED SUBSEQUENT TO THIS PROCESS IMPROVEMENT. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THE COMPLAINT COMPONENT SURGICAL POLYISOPRENE GLOVES, PART NUMBER 48330 IS MANUFACTURED BY ANSELL (FDA REGISTRATION 8041180). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON JULY 7, 2023. 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 COMP-(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.

    Description of Event or Problem · 0

    AN INCIDENT OCCURRED DURING A PROCEDURE USING THE GLOVES WITH A PATIENT. THERE WAS NO MEDICAL INTERVENTION/INJURY THAT OCCURRED ON THE PART OF THE USER OR THE PATIENT. THIS INCIDENT CAUSED A BREACH IN STERILITY. GIVEN THE HOLES WERE DISCOVERED DURING SURGICAL PROCEDURE, THIS INCIDENT HAS BEEN EVALUATED BY THE COMPLAINT HANDLING SITE TO BE A REPORTABLE MALFUNCTION THAT COULD LEAD TO A SERIOUS INJURY OR ILLNESS IF IT WERE TO RECUR DURING THE COURSE OF A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921218 HALYARD* POLYISOPRENE/NEOPRENE HYBRID POWDER-FREE STERILE SURGICAL GLOVES SURGICAL GLOVES POLYISOPRENE KGO O&M HALYARD, INC. 48330 22050858058 30680651483301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown