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

Catalog Number 9575

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/09/2019

Event Type  malfunction  

Event Description

A non-reinforced surgical gown came from the manufacturer wrapped improperly rendering it non-sterile.This was noticed before it was opened to the surgical field; however, had it been opened it would have contaminated the entire field.The gown was set aside in the wrapping and the information will be circulated though the unit to provide education and prevent contamination of any cases.

• Brand Name: CONVERTORS
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8357214
• MDR Text Key: 136730775
• Report Number: 8357214
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 9575
• Device Lot Number: 18KBJ027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2019
• Type of Device Usage: N
• Patient Sequence Number: 1