MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC STERILE ORTHO PACK; GENERAL SURGERY TRAY

Catalog Number SOP11BSCTS

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Event Description

Bioburden found in sterile ortho pack.Patient not in room.The suite was broken down and reset up.No harm to patient.

• Brand Name: STERILE ORTHO PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1400 s. waukegan road
• MDR Report Key: 7650268
• MDR Text Key: 112896933
• Report Number: MW5078153
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SOP11BSCTS
• Device Lot Number: 477751
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1