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

Lot Number NL6052

Device Problem Break (1069)

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

Event Date 11/13/2019

Event Type  malfunction  

Event Description

A 4 mm pituitary (v.Mueller) nl6052, broken while in use.X-ray taken, no visible parts seen on x-ray.No detectable harm.Fda safety report id# (b)(4).

• Brand Name: V. MUELLER 4 MM PITUITARY
• Type of Device: FORCEPS
• Manufacturer (Section D): BD / CAREFUSION 2200, INC.
• MDR Report Key: 9539119
• MDR Text Key: 173514105
• Report Number: MW5091967
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: NL6052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• 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 Age: 84 YR