MAUDE Adverse Event Report: TELEFLEX MEDICAL DEKNATEL EK BL MF 0 TC-43/HR 26 N; SUTURE NEEDLE

Catalog Number 833-124

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

Alleged issue: during the procedure, the surgeon placed the suture.When the surgeon removed the capio slim device, the bullet head of the suture was missing.It was confirmed that the bullet remained inside the patient.A second capio slim device and second suture was used to complete the case.No patient complications.Patient current condition reported, as fine.

Manufacturer Narrative

Qn#: (b)(4).No sample is available for the mfr to evaluate.

• Brand Name: DEKNATEL EK BL MF 0 TC-43/HR 26 N
• Type of Device: SUTURE NEEDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4801691
• MDR Text Key: 5926579
• Report Number: 3004365956-2015-00154
• Device Sequence Number: 1
• Product Code: GAO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 833-124
• Device Lot Number: 74E1400235
• Other Device ID Number: 1900038557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1