MAUDE Adverse Event Report: BD / CAREFUSION 2200, INC 4 MM V. MUELLER; RONGEUR, MANUAL

Model Number NL6052

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2020

Event Type  Injury  

Event Description

Mouth of instrument did not close properly when in use.Fda safety report id # (b)(4).

• Brand Name: 4 MM V. MUELLER
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): BD / CAREFUSION 2200, INC; franklin lakes NJ 07417
• MDR Report Key: 10837640
• MDR Text Key: 216409899
• Report Number: MW5097859
• Device Sequence Number: 1
• Product Code: HAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL6052
• Device Catalogue Number: NL6052
• Device Lot Number: B20XWD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR