MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CONVERTORS; GOWN, SURGICAL

Model Number 9575

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/19/2019

Event Type  malfunction  

Event Description

The dust cover was taken off of a sterile gown to open it onto the operative field and noticed that the blue wrap was not fully covering the gown, therefore making the gown contaminated.The gown with identifying paper work to the manager.This is not the first time this has happened.The gowns are coming from the manufacturer this way.

• Brand Name: CONVERTORS
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8357205
• MDR Text Key: 136730305
• Report Number: 8357205
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380153525
• UDI-Public: (01)10885380153525(17)231001(10)18KBJ027
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9575
• Device Catalogue Number: 9575
• Device Lot Number: 18KBJ027
• 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: 02/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2019
• Type of Device Usage: N
• Patient Sequence Number: 1