MAUDE Adverse Event Report: CAREFUSION 2200, INC. CAREFUSION CIRCUMCISION TRAY; CLAMP, CIRCUMCISION

Device Problem Failure to Cut (2587)

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

Event Date 08/14/2020

Event Type  malfunction  

Event Description

The scissors from the circumcision kit would not cut the foreskin.He used a scalpel and a pair of sterile scissors.Fda safety report id# (b)(4).

• Brand Name: CAREFUSION CIRCUMCISION TRAY
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CAREFUSION 2200, INC. ; vernon hills IL 60061
• MDR Report Key: 10448082
• MDR Text Key: 204414358
• Report Number: MW5096221
• Device Sequence Number: 1
• Product Code: HFX
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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 Age: 1 DA
• Patient Weight: 3