MAUDE Adverse Event Report: HALYARD HALYARD; HALYARD C-SECTION/ABDOMINAL COLLECTION DRAPE WITH FINESTRATED INCISE

Catalog Number	79526
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
C-section drape had strike through during a c-section.The adhesive on the drape pouch that collects the fluid failed, which resulted in the fluids being spilled on floor of procedural room and staff.

• Brand Name: HALYARD
• Common Device Name: HALYARD C-SECTION/ABDOMINAL COLLECTION DRAPE WITH FINESTRATED INCISE
• Manufacturer (Section D): HALYARD; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): HALYARD; 5405 windward parkway; alpharetta GA 30004
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 17976822
• Report Number: 3014527682-2023-00016
• Device Sequence Number: 2454219
• Product Code: KKX
• UDI-Device Identifier: 30680651795268
• UDI-Public: 30680651795268
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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 Catalogue Number: 79526
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown