BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOARTS BODY SPLIT DRAPE 88X116 10

    MDR report key: 20063340 · Received August 26, 2024

    Report

    Report Number
    3005997949-2024-00008
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 28, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651892752
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS RETURNED FOR EVALUATION. SAMPLE EVALUATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. 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 AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    SAMPLE WAS RECEIVED AND ONE HAIR APPROXIMATELY 24 INCHES WAS CONFIRMED. ROOT CAUSE IS LIKELY OPERATOR FAILURE TO FOLLOW GOWNING PROCEDURES (DONNING OF HEAD COVERING PRIOR TO ENTRY IN ASSEMBLY AREAS). PERSONNEL HAVE BEEN NOTIFIED OF THIS ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THIS LOT AND NO CONTRIBUTING ISSUES WERE FOUND. 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 FOREIGN MATERIAL WAS FOUND IN THE PRODUCT, THIS CAUSED A 30-MINUTE DELAY IN PROCEDURE STARTING. THE PATIENT WAS NOT ADVERSELY AFFECTED OTHER THAN DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294049 ORTHOARTS BODY SPLIT DRAPE 88X116 10 SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 89275 AC2414204F 30680651892752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown