MAUDE Adverse Event Report: TELEFLEX MEDICAL THORACIC TROCAR CATH 10FR SOFT 10/CS; CATHETER, IRRIGATION

Catalog Number	DTRC-10S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that, "we were placing one of them yesterday and the knob broke off of the stylet after placement, causing the use of hemostats to remove stylet, which caused displacement." additional information received states that the incident "led to baby having to have another chest tube to be placed.Baby is critical but stable".
Event or Problem Description
It was reported that, "we were placing one of them yesterday and the knob broke off of the stylet after placement, causing the use of hemostats to remove stylet, which caused displacement." additional information received states that the incident "led to baby having to have another chest tube to be placed.Baby is critical but stable".
Additional Manufacturer Narrative
(b)(4).One unit was received for evaluation.Sample was not received in its original packaging.The rod and the catheter are not assembled.No broken issues between knob and rod were observed.A device history record review was performed, and no relevant findings were identified.No corrections can be established at this moment since no problem found on sample.Customer complaint cannot be confirmed since no problem found on sample.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.

• Brand Name: THORACIC TROCAR CATH 10FR SOFT 10/CS
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18941940
• Report Number: 3004365956-2024-00027
• Device Sequence Number: 16867419
• Product Code: GBX
• UDI-Device Identifier: 04026704558506
• UDI-Public: 04026704558506
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DTRC-10S
• Device Lot Number: 74L2300428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown