BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYE DRAPE WITH DOUBLE POUCH 55 IN. X 76 IN.

    MDR report key: 19826243 · Received July 25, 2024

    Report

    Report Number
    3014421917-2024-00007
    Event Type
    Injury
    Date Received
    July 25, 2024
    Report Date
    August 13, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651763465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT ONE OF TWO. THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE COMPLAINT PRODUCT. THE PRODUCT IS CONTRACT MANUFACTURED BY PRINCIPLE & WILL BIOTECH (PINGHU) CO., LTD. (FDA REGISTRATION NUMBER 3006973666). A SCAR WAS ISSUED TO THE CONTRACT MANUFACTURER ON JULY 3, 2024. 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 (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

    INCIDENT ONE OF TWO. A SAMPLE OR PHOTO WAS NOT PROVIDED FOR INVESTIGATION. THE COMPONENTS WERE ASSEMBLED BY USING DOUBLE-SIDED TAPE. NO HOT-MELT OR COLD GLUE WAS USED ON THIS DRAPE. THE CUSTOMER DID NOT PROVIDE A COMPLAINT LOT NUMBER; THEREFORE, THE MANUFACTURING SITE CANNOT REVIEW DEVICE HISTORY RECORDS INCLUDING INSPECTION DOCUMENTATION. COMPLAINT DATABASE WAS REVIEWED (B)(6) 2023- (B)(6) 2024, THERE ARE NO OTHER COMPLAINTS OF THIS NATURE FOUND. A ROOT CAUSE WAS NOT IDENTIFIED. THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED FOR IMPLEMENTATION TO MINIMIZE OPPORTUNITY FOR RECURRENCE: EMPLOYEES WERE TRAINED ON THE FOLLOWING PREVENTIVE MEASURES: 1. IQC SHOULD CAREFULLY INSPECT INCOMING MATERIALS AS PER THE MATERIAL INCOMING INSPECTION WORK INSTRUCTION AND REPORT ANY ANOMALIES IMMEDIATELY. 2. EMPLOYEES MUST BE VIGILANT DURING PRODUCTION, REPORT ANY GLUE RESIDUE TO MANAGEMENT. 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

    INCIDENT ONE OF TWO. TWO COMPLAINTS FROM THE SAME END-USER WERE RECEIVED REGARDING DRAPE PRODUCT 76346. THE GLUE RESIDUE OF THE DRAPE WAS ON THE PATIENT'S EYE DURING INTRA OCULAR LENS IMPLANTATION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE INCIDENT, BUT THE PATIENT IMPACT WAS UNKNOWN. NO LOT NUMBER WAS PROVIDED OR KNOWN BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357525 EYE DRAPE WITH DOUBLE POUCH 55 IN. X 76 IN. SURGICAL DRAPES PUI O&M HALYARD, INC. 76346 UNKNOWN 30680651763465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other