BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA-LONG LOWER EXTREMITY DRAPE

    MDR report key: 20989202 · Received December 20, 2024

    Report

    Report Number
    3005997949-2024-00011
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 22, 2024
    Report Date
    January 22, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651292231
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR COMPLAINT LOT WAS REVIEWED, PRODUCT WAS FOUND TO MEET ALL PRODUCT SPECIFICATIONS AND RELEASE REQUIREMENTS. NO ISSUES WERE DOCUMENTED DURING MANUFACTURE WHICH WOULD CONTRIBUTE TO THIS FAILURE. INVESTIGATION CONCLUDED THE REPORTED DRAPE HOLE WAS CAUSED BY AN UNGLUED AREA (ADHESIVE ISSUE). THIS IS THE FIRST INCIDENT REPORTED FOR OPEN GUSSETS ON THIS PRODUCT, THIS INCIDENT IS CONSIDERED AN ISOLATED EVENT. PERSONNEL INVOLVED IN MANUFACTURING WERE NOTIFIED OF THE INCIDENT TO RAISE AWARENESS. 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 21 CFR 803, 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 THIS COMPLAINT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION. 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

    DURING THE PROCEDURE, A TEAR WAS DISCOVERED IN THE DRAPE. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL TREATMENT REQUIRED. STERILE FIELD WAS COMPROMISED DUE TO TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061392 EXTRA-LONG LOWER EXTREMITY DRAPE SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 29223 AC24051261 30680651292231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown