BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD* POLYISOPRENE MICRO SURGICAL GLOVES

    MDR report key: 17088544 · Received June 8, 2023

    Report

    Report Number
    3014421917-2023-00005
    Event Type
    Injury
    Date Received
    June 8, 2023
    Date of Event
    May 9, 2023
    Report Date
    August 30, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    KGO
    UDI-DI
    30680651483172
    PMA / PMN Number
    K071746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 COMPONENT SURGICAL POLYISOPRENE GLOVES, PART NUMBER: 48317 IS MANUFACTURED BY ANSELL (FDA REGISTRATION: 8041180). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON 12MAY2023. 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

    CORRECTION: PLEASE NOTE, THE REPORT WAS A MALFUNCTION FOR WHICH O&M HALYARD IS NOT THE LEGAL MANUFACTURER BUT WE ARE THE INITIAL IMPORTER. THE LEGAL MANUFACTURER HAS BEEN MADE AWARE. O&M HALYARD FILED INITIAL REPORT WITH THE FDA IN ERROR. PER 21 CFR 803.40, IMPORTERS ARE REQUIRED TO SEND REPORTS OF DEVICE-RELATED DEATHS AND SERIOUS INJURIES TO FDA. THIS COMPLAINT IS A MALFUNCTION WHEREBY NO SERIOUS INJURY OR DEATH WAS REPORTED. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURER (ANSELL) HAS REPLIED TO O&M HALYARD SUPPLIER CORRECTIVE ACTION REQUEST INDICATING THAT INVESTIGATION WAS LIMITED DUE TO NO LOT NUMBER OR SAMPLES PROVIDED. THE MANUFACTURER INDICATED THAT THE CALCIUM CARBONATE TYPE CHANGED FROM PRECARB+SUPERLITE TO SUPERLITE GROUND CALCIUM CARBONATE IN FEBRUARY 2023. WITHOUT AN INDICATED LOT NUMBER, THE MANUFACTURER ISN'T SURE THIS COMPLAINT INCIDENT INVOLVED A LOT MANUFACTURED BEFORE OR AFTER THIS CHANGE. THEY WILL BE MONITORING ALL COMPLAINTS FOR THIS PRODUCT TYPE TO ENSURE THERE ARE NO TREND(S) FOR THIS ISSUE. 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AN INCIDENT OCCURRED SEVERAL TIMES DURING DONNING OF THE GLOVES PRIOR TO USE AND AFTER USE WITH PATIENTS. THERE WAS NO MEDICAL INTERVENTION/INJURY OR EMPLOYEE HEALTH VISITS THAT OCCURRED ON THE PART OF THE USER OR PATIENT. THE HOLES WERE FOUND IN THE GLOVES NOT THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762722 HALYARD* POLYISOPRENE MICRO SURGICAL GLOVES SURGICAL GLOVES POLYISOPRENE KGO O&M HALYARD, INC. 48317 UNKNOWN 30680651483172

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other