MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY

Model Number	100/870/085
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes blue line ultra (blu) reported damage cuff with pierced balloon, which required removal and new tracheostomy, in turn this was compromising oxygenation of patient.It was reported he cuff was not assessed prior to insertion.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 11859171
• Report Number: 3012307300-2021-04742
• Device Sequence Number: 14200660
• Product Code: BTO
• UDI-Device Identifier: 15019315038815
• UDI-Public: 15019315038815
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/20/2021

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: 07/10/2025
• Device Model Number: 100/870/085
• Device Catalogue Number: 100/870/085
• Device Lot Number: 3995990
• 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: 04/22/2021
• Initial Report FDA Received Date: 05/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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