MAUDE Adverse Event Report: CASE MEDICAL, INC. STERITITE STERILIZATION CONTAINER; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Device Problems Improper or Incorrect Procedure or Method (2017); Lack of Maintenance Documentation or Guidelines (2971)

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

Event Date 03/18/2019

Event Type  malfunction  

Event Description

The manufacturing changed the material in a sterilization container without proper documentation and study being conducted.

• Brand Name: STERITITE STERILIZATION CONTAINER
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): CASE MEDICAL, INC.
• MDR Report Key: 8470509
• MDR Text Key: 140595373
• Report Number: MW5085416
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1