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

Model Number ORT04B

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2017

Event Type  malfunction  

Event 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
• Type of Device: DRAPE, SURGICAL
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood boulevard; mechanicsville VA 23116
• MDR Report Key: 7074294
• MDR Text Key: 93493058
• Report Number: 7074294
• Device Sequence Number: 1
• Product Code: KKX
• UDI-Device Identifier: 10885632101724
• UDI-Public: (01)10885632101724
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/25/2022
• Device Model Number: ORT04B
• Device Lot Number: 1705GD09B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1