MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43/HR 26 2N; SUTURE, NONABSORBABLE, SYNTHE

Catalog Number 833-124

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that when they attached the suture to the capio device the suture string unraveled and the bullet was left in the patient.They opened a new capio and a new suture of the same kind to complete the case.No patient complications reported.The patient was fine.The problem was noticed during procedure and it occurred inside of the patient.

Event Description

It was reported that when they attached the suture to the capio device the suture string unraveled and the bullet was left in the patient.They opened a new capio and a new suture of the same kind to complete the case.No patient complications reported.The patient was fine.The problem was noticed during procedure and it occurred inside of the patient.

Manufacturer Narrative

(b)(4).A dhr review could not be conducted since the lot number was not provided.Per ha-000039 rev.12 line: operational hazards - incorrect or inappropriate output or functionality - needle disengages/separates from suture when used with an accesory and/or suturing device: when the suture is used with an accesory and/or suturing device the suture maybe subject to forces that are under control of the surgeon using the device.Ifu 163566 and 163567: precautions, states the following: avoid excessive handling i.E.Crushing or crimping resulting from use of s urgical instruments such as forceps and needle holders.No corrective action can be implemented due to the lack of product code and batch number to perform a proper investigation to determine a root cause.

• Brand Name: DEK BL MF 0 TC-43/HR 26 2N
• Type of Device: SUTURE, NONABSORBABLE, SYNTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 9118442
• MDR Text Key: 194669600
• Report Number: 3004365956-2019-00267
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K930738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 833-124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1