MAUDE Adverse Event Report: TELEFLEX TELEFLEX CAPIO SUTURE

Catalog Number 833-213

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/23/2014

Event Type  Injury  

Event Description

The bulleted needle popped off the suture and was lost in the patient.

• Brand Name: TELEFLEX CAPIO SUTURE
• Type of Device: CAPIO SUTURE
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• MDR Report Key: 4217309
• MDR Text Key: 5071211
• Report Number: MW5038894
• Device Sequence Number: 1
• Product Code: MFJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: 833-213
• Device Lot Number: 02A1401752
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 78