MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER; RONGEUR, MANUAL

Model Number NL4261-83

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/11/2020

Event Type  malfunction  

Event Description

The screw became dislodged from the device, and fell out into the patient.

• Brand Name: V. MUELLER
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10470909
• MDR Text Key: 204914988
• Report Number: 10470909
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2020,04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NL4261-83
• Device Catalogue Number: NL4261-83
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2020
• Date Report to Manufacturer: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA