MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SMARTSLEEVE POLY-REINFORCED BREATHABLE SLEEVE SURGICAL GOWNS; GOWN, SURGICAL

Model Number 9011EL

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

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

Event Date 07/18/2018

Event Type  malfunction  

Event Description

During a shoulder surgery case there was a strike through of large amount of bloody fluid.This was a level 4 gown opened separately, was not part of the shoulder pack.

• Brand Name: SMARTSLEEVE POLY-REINFORCED BREATHABLE SLEEVE SURGICAL GOWNS
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 7859572
• MDR Text Key: 119661030
• Report Number: 7859572
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9011EL
• Device Catalogue Number: 9011EL
• Device Lot Number: 18EMD146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2018
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1