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

Catalog Number 520000

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Abrasion (1689)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: only the day (01) and year (2020) of the event date is known.The month is unknown.

Event Description

It was reported the tracheostomy tube fixation band did not properly hold in place the device, causing irritation and continuous injury in the affected area.The defect caused lesions in the affected area and incorrect positioning of the cannula itself.No patient injury or further complications were reported in relation to this event.

• Brand Name: PORTEX TUBE HOLDER
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10581434
• MDR Text Key: 208382092
• Report Number: 3012307300-2020-09774
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 520000
• Device Lot Number: U1926625
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1