BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17557991 · Received August 16, 2023

    Report

    Report Number
    3014421917-2023-00007
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Report Date
    October 31, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    KGO
    UDI-DI
    30680651483271
    PMA / PMN Number
    K151694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE
    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 AND NO ABNORMALITIES WERE FOUND. AN INVESTIGATION WAS CARRIED OUT BY REVIEWING ALL THE DATA INCLUDING PRODUCTION AND PACKING DEVICE HISTORY RECORDS, COMPLAINT HISTORY AND INTERNAL DEFECT TRENDS. THE LOT PASSED AT 0.65 AQL INSPECTION. THE MANUFACTURER (ANSELL) IMPLEMENTED SEVERAL CORRECTIVE ACTIONS, INCLUDING: VALIDATION TO IMPROVE THE HOMOGENEITY OF COAGULANT APPLICATION, NEW INSPECTION CHECKLIST TO INSPECT ALL FORMERS, AND A CHECKLIST HAS BEEN ESTABLISHED TO MONITOR FOR SHARP EDGES OF GLOVE BINS AND EQUIPMENT. 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

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THE COMPLAINT COMPONENT SURGICAL POLYISOPRENE GLOVES, PART NUMBER 48327 IS MANUFACTURED BY ANSELL (FDA REGISTRATION 8041180). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON JULY 20, 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 (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

    THE CUSTOMER STATED A HOLE DEVELOPED DURING USE WITH THE NITRILE GLOVE. ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INCIDENT INFORMATION ON (B)(6) 2023. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895863 HALYARD * POLYISOPRENE/NEOPRENE HYBRID POWDER-FREE STERILE SURGICAL GLOVES SURGICAL GLOVES POLYISOPRENE KGO O&M HALYARD, INC. 48327 2205083305 30680651483271

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown