MAUDE Adverse Event Report: NULL PORTEX ENDOTRACHEAL TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/150/070

Device Problem Complete Blockage (1094)

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

Event Date 01/17/2021

Event Type  Injury  

Event Description

It was reported that the tube became kinked and collapsed and this caused ventilation problems.Patient required reintubation.

Manufacturer Narrative

No device was returned for investigation.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 13358967
• MDR Text Key: 284464528
• Report Number: 3012307300-2022-01758
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K173912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 100/150/070
• Device Lot Number: 200403070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening