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

Model Number	47617
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We opened a medium drape and it had what looks like a piece of an ironing board cover from the manufacturer in the sterile pack, it did not come in contact with the patient.Unknown material, possibly gray colored compressed dust, in inner fold of drape.

• Brand Name: HALYARD
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• Manufacturer (Section D): OM HALYARD, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 10835718
• Report Number: 10835718
• Device Sequence Number: 3595274
• Product Code: PUI
• UDI-Device Identifier: 10680651476170
• UDI-Public: (01)10680651476170(17)250709(10)AC2019105E
• 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): 10/30/2020
• Report Date (Section F): 10/30/2020

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: 47617
• Device Catalogue Number: 47617
• Device Lot Number: AC2019105E
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/30/2020