MAUDE Adverse Event Report: ST PAUL PORTEX AIRWAY NASOPHARYNGEAL; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/210/070

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Blood Loss (2597)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the airway was very rigid and causing bleeding to the patient.No further complications were reported in relation to this event.Additional information had been requested but has not yet been received.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Other, other text: additional information that this occurred on both sized of et tubes.

• Brand Name: PORTEX AIRWAY NASOPHARYNGEAL
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10951878
• MDR Text Key: 219883375
• Report Number: 3012307300-2020-12148
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/26/2024
• Device Catalogue Number: 100/210/070
• Device Lot Number: 3797570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1