MAUDE Adverse Event Report: OM HALYARD, INC. HALYARD; DRAPE, SURGICAL

Model Number	89454
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Broken yankauer in the trauma abdominal pack.

• Brand Name: HALYARD
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): OM HALYARD, INC.; 1220 old alpharetta rd; suite 320; alpharetta GA 30005
• MDR Report Key: 25147613
• Report Number: 25147613
• Device Sequence Number: 9351276
• Product Code: KKX
• UDI-Device Identifier: 10680651894547
• UDI-Public: 10680651894547
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/06/2026
• Report Date (Section F): 05/06/2026

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: 89454
• Device Catalogue Number: 300924
• Device Lot Number: CA25268XXX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Date Report Sent to FDA: 05/06/2026