MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE; DRAPE, SURGICAL

Model Number	ORT04B
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A hair was found inside the sterile package of a disposable or towel.This was discovered prior to the towels being introduced to the sterile field.The contaminated package was removed and replaced.The procedure was completed as planned with no patient contamination.Per site reporter: response from the manufacturer is still pending.We will return pack for investigation.

• Brand Name: MEDICHOICE
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood boulevard; mechanicsville VA 23116
• MDR Report Key: 7074294
• Report Number: 7074294
• Device Sequence Number: 19115753
• Product Code: KKX
• UDI-Device Identifier: 10885632101724
• UDI-Public: (01)10885632101724
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2017
• Report Date (Section F): 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 05/25/2022
• Device Model Number: ORT04B
• Device Lot Number: 1705GD09B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2017
• 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: 11/20/2017