MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY

Model Number	100/870/080
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Airway Obstruction (1699)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy pvc - portex tubes blue line ultra (blu) tip of the sub glottic port has cracked.Patient required immediate tracheostomy change out.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 11711947
• Report Number: 3012307300-2021-03380
• Device Sequence Number: 3765637
• Product Code: BTO
• UDI-Device Identifier: 15019315038808
• UDI-Public: 15019315038808
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/01/2025
• Device Model Number: 100/870/080
• Device Catalogue Number: 100/870/080
• Device Lot Number: 4039627
• 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: 03/24/2021
• Initial Report FDA Received Date: 04/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening