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

Lot Number 0001364074

Device Problem Failure to Cut (2587)

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

Event Date 09/25/2020

Event Type  malfunction  

Event Description

Scissors noted to not cut foreskin, had to open another kit.Fda safety report id# (b)(4).

• Brand Name: CIRCUMCISION TRAY
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CAREFUSION 2200, INC. ; vernon hills IL 76012 6006
• MDR Report Key: 10612953
• MDR Text Key: 209568463
• Report Number: MW5096980
• Device Sequence Number: 1
• Product Code: HFX
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0001364074
• 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: 5 DA
• Patient Weight: 3