MAUDE Adverse Event Report: CAREFUSION 2200, INC ARTICULATING TRIANGULAR RETRACTOR, 80 MM

Model Number 89-6110

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Event Description

"coat hanger" piece of retractor broke inside of patient; all pieces retrieved; x-rays negative per radiology.No patient harm.

• Brand Name: ARTICULATING TRIANGULAR RETRACTOR, 80 MM
• Type of Device: RETRACTOR
• Manufacturer (Section D): CAREFUSION 2200, INC; 5 sunnen dr.; saint louis MO 63143
• MDR Report Key: 10337471
• MDR Text Key: 200797784
• Report Number: 10337471
• Device Sequence Number: 1
• Product Code: GAD
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 89-6110
• Device Catalogue Number: 89-6110
• 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: 07/21/2020
• Device Age: 4 YR
• Date Report to Manufacturer: 07/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1