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

Catalog Number ORT04B

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2017

Event Type  malfunction  

Event Description

Upon opening a pack of sterile blue towels, a white hair was discovered within the pile of towels.The towels were within the sterile field.The table had to be torn down and surgical disposables had to be re-pulled.The procedure was completed without further indecent.No harm came to the patient.Per reporter the device will be returned to the manufacturer for failure analysis.

• Brand Name: MEDICHOICE
• Type of Device: DRAPE, SURGICAL
• Manufacturer (Section D): OWENS &; MINOR DISTRIBUTION, INC.; 9120 lockwood boulevard; mechanicsville VA 23116
• MDR Report Key: 6402042
• MDR Text Key: 69895194
• Report Number: 6402042
• Device Sequence Number: 1
• Product Code: KKX
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ORT04B
• Device Lot Number: 1607GD09C
• 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: 03/08/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• 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