MAUDE Adverse Event Report: TELEFLEX MEDICAL TEV GN BR 0 TC-43 2N 48"

Catalog Number 833-113

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: it was reported that the bullet head detached from the suture during the first throw.This was noticed after the surgeon removed the capio.The bullet head is believed to have remained in the patient.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The device history record of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection reports were originated for the lot in question that can be associated to the complaint reported.The device history record shows that the product was assembled and inspected according to the manufacturer's specifications.

• Brand Name: TEV GN BR 0 TC-43 2N 48"
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 5289998
• MDR Text Key: 33926309
• Report Number: 3004365956-2015-00421
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2020
• Device Catalogue Number: 833-113
• Device Lot Number: 74B1501497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1