MAUDE Adverse Event Report: SULTAN HEALTHCARE INC ASSUREPLUS®; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES OTHER ACCESSORIES

Model Number 83000

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 05/19/2020

Event Type  malfunction  

Event Description

While placing endotracheal tube (ett) bone on post-op infant, it was noticed that the bone did not have a hole in it and the ett was clamped.Device removed and new ett bone placed.

• Brand Name: ASSUREPLUS®
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES OTHER ACCESSORIES
• Manufacturer (Section D): SULTAN HEALTHCARE INC; 221 w philadelphia st ste 60; york PA 17401
• MDR Report Key: 10205879
• MDR Text Key: 196771138
• Report Number: 10205879
• Device Sequence Number: 1
• Product Code: KCT
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 83000
• Device Catalogue Number: 83000
• 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: 06/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1