MAUDE Adverse Event Report: CAREFUSION CAREFUSION CIRCUMCISION TRAY OB-100; CLAMP, CIRCUMCISION

Lot Number 0001328893

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/25/2020

Event Type  malfunction  

Event Description

Hemostat would not grip the tissue.Fda safety report id# (b)(4).

• Brand Name: CAREFUSION CIRCUMCISION TRAY OB-100
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CAREFUSION ; vernon hills IL 60061
• MDR Report Key: 9793397
• MDR Text Key: 182543820
• Report Number: MW5093540
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0001328893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2020
• 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