MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	100/562/000
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the guide wire of a smiths medical tracheostomy|pvc - portex tubes pdt ultraperc would kink during placement, making it very difficult to place.No patient consequences were reported.No adverse effects were reported.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• MDR Report Key: 12520537
• Report Number: 3012307300-2021-09565
• Device Sequence Number: 11869119
• Product Code: JOH
• UDI-Device Identifier: 15019315042829
• UDI-Public: 15019315042829
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K040014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: No Information
• Device Expiration Date: 11/01/2023
• Device Model Number: 100/562/000
• Device Catalogue Number: 100/562/000
• Device Lot Number: 4070538
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1