MAUDE Adverse Event Report: BECTON, DICKINSON & CO. / CAREFUSION 2200, INC. BECTON, DICKINSON & CO. KERRISON RONGEUR, MANUAL

Lot Number 4251-83T

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

A 3mm z-coat kerrison tip broke routine/proper use. Per scrub rn, broken piece retrieved from surgical incision field and broken piece fits exactly with kerrison instrument. Removed from back table. Broken instrument labeled and sent down to spd on case cart. Fda safety report id# (b)(4).

• Brand Name: BECTON, DICKINSON & CO. KERRISON
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. / CAREFUSION 2200, INC.
• MDR Report Key: 11107969
• MDR Text Key: 225079004
• Report Number: MW5098617
• 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: 12/29/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 4251-83T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage