MAUDE Adverse Event Report: TELEFLEX MEDICAL MDK VI MF 0 TC-43/HR26 48"

Catalog Number 833-137LP

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) a visual nor functional inspection of the product involved in the complaint could not be conducted since the product was not returned.An attempt to duplicate the failure mode was not made because at the time there is no inventory of the involved product code available at the facility nor is it being manufactured at the time.If the defective samples become available at a later date, this complaint will be updated accordingly.The device history review could not be conducted since the lot number was not provided.The customer complaint cannot be confirmed and no corrective actions can be implemented due the lack of product sample and batch number to perform a proper investigation and determine the root cause.Teleflex will continue to monitor and trend related events.

Event Description

Placing monodek suture left sacrospinous ligament, monodek bullet and approximately 1cm of capio suture device metal ring pulled off of the suture.Monodek bullet 26.2mm in size along with 1cm of metal ring was not attainable by the physicians.The patient's condition is unknown at this time.

• Brand Name: MDK VI MF 0 TC-43/HR26 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 27560 ; 9194332672
• MDR Report Key: 6722733
• MDR Text Key: 80536255
• Report Number: 3004365956-2017-00287
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 833-137LP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2017
• 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: N
• Patient Sequence Number: 1