MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD; DRAPE, SURGICAL

Model Number	89601
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Halyard mayo stand cover was opened for procedure.When placed on mayo stand to drape, it was found both ends of the drape were open.

• Brand Name: HALYARD
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd ste 320; alpharetta GA 30005
• MDR Report Key: 21229396
• Report Number: 21229396
• Device Sequence Number: 20966063
• Product Code: KKX
• UDI-Device Identifier: 10680651896015
• UDI-Public: (01)10680651896015(11)240609(17)290609(10)AC2416102C
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2025
• Report Date (Section F): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89601
• Device Catalogue Number: 89601
• Device Lot Number: AC2416102C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/08/2025