MAUDE Adverse Event Report: CENTURION MEDICLA PRODUCTS CENTURION CIRCLAMP; HFX; CLAMP, CIRCUMCISION

Model Number 110CR,130CRA,145CR

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 07/01/2014

Event Type  Injury  

Event Description

We had two physicians complain when they perform circumcisions this weekend.When they perform the circumcision, there was blood during the process.At first, we suspected the clamp in the circumcision tray.(cit5120) after talking with a nurse in the nursery, we discovered the issue is the package containing the bell and two washers.It appears the washers are not meeting tightly, when they are placed in the clamp, allowing the blood.Three different centurion circlamp bell-insert model numbers were reported to be in the hospital's inventory.The three model numbers were 110cr, 130cra and 145cr.The hospital was unsure as to which model number was involved.

• Brand Name: CENTURION CIRCLAMP
• Type of Device: HFX; CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICLA PRODUCTS; howell MI
• Manufacturer (Section G): CENTURION MEDICAL PRODUCTS; howell MI 48843
• Manufacturer Contact: matthew price ; 100 centurion way; williamston, MI 48895 ; 5175451135
• MDR Report Key: 4098112
• MDR Text Key: 4839255
• Report Number: 1824619-2014-00001
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110CR,130CRA,145CR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention