MAUDE Adverse Event Report: TELEFLEX MEDICAL THORACIC TROCAR CATH 16FR SOFT; CATHETER, IRRIGATION

Model Number	IPN028472
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).From the pictures provided it was unable to confirm the failure mode reported as radiopaque markings not visible.It is necessary to receive the physical sample to perform a proper investigation, determine root cause, and implement corrective actions.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.No additional test was performed.Verification of failure mode reported in the current manufacturing process could not be performed because the product was not being manufactured.The device history record of batch number 74d2000714 that belongs to material dtrc-16s has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.
Event or Problem Description
There is a complaint that the surgeon not being able to see the radiopaque markings on the dtrc-16s catheter.They have a lot for the dtrc-20s catheters that they have on the shelf, but not for the dtrc-16s.They would have to look into order history to see when the last order placed for dtrc-16s was to try and obtain the lot from that order.Additional information from medwatch report# (b)(4).The patient had 2 chest tubes placed, and neither had a radiopaque marking to verify its location in the chest.Physician arrived on a monday morning and my partner had already reviewed the films, noting that it appeared both chest tubes appeared to be outside the chest of this critically ill patient (as no radiopaque markings were seen over the lung fields).Physician reported they have never heard of a chest tube without radiopaque markings, but these teleflex tubes do not have them.It made physicians worry that this critically ill patient might be at high risk of rapid death due to tension pneumothorax; when physician heard that the chest tubes did not appear to be in the chest, the first thing physician did was to go and get equipment to put in new chest tubes - that would be the rate limiting step here.When physician then was getting ready to place them, physician inspected both tubes and found them buried to the hub, clearly in the chest and functioning.

• Brand Name: THORACIC TROCAR CATH 16FR SOFT
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11243116
• Report Number: 3003898360-2021-00025
• Device Sequence Number: 11651719
• Product Code: GBX
• UDI-Device Identifier: 14026704631534
• UDI-Public: 14026704631534
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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 Expiration Date: 04/10/2023
• Device Model Number: IPN028472
• Device Catalogue Number: DTRC-16S
• Device Lot Number: 74D2000714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1