MAUDE Adverse Event Report: TELEFLEX CAPIO SUTURING DEVICE; SUTURE

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

Alleged issue: the bullet came off the suture.The patient's condition is reported as fine.

Manufacturer Narrative

A device history report review (dhr) or root cause could not be conducted since the lot number was not provided and no sample returned.The manufacturer will continue to monitor and trend related complaints.

• Brand Name: CAPIO SUTURING DEVICE
• Type of Device: SUTURE
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: effie jefferson, rn ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 3997990
• MDR Text Key: 4705919
• Report Number: 3004365956-2014-00242
• Device Sequence Number: 1
• Product Code: MFJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1