MAUDE Adverse Event Report: TELEFLEX INCORPORATED PLEUR-EVAC THORACIC CATHETER; CATHETER, IRRIGATION

Catalog Number DTRC-16S

Device Problems Display or Visual Feedback Problem (1184); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Event Description

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 didn't 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.Update: same issue last evening, chest x-ray read by radiologist.Radiologist unable to visualize chest tube.Valuable time was used to clarify this as the radiologist had to contact physician and physician had to explain that the tube was actually in the chest.The radiopaque needs to be easily visible and compromises safety when the radiopaque line is not.It also causes unnecessary waste of time for physicians and radiologists.It was also noted that the 20 fr teleflex tubes have a very think radiopaque line.Photos available.

• Brand Name: PLEUR-EVAC THORACIC CATHETER
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11162969
• MDR Text Key: 226620970
• Report Number: 11162969
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2021,12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DTRC-16S
• Device Lot Number: 129702
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA