MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/870/080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex® blue line ultra® tracheostomy tube was reported to be leaking two hours after placement.A trach tube change out was performed with no reported adverse patient effects.

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• MDR Report Key: 9919204
• Report Number: 3012307300-2020-02659
• Device Sequence Number: 16976583
• Product Code: BTO
• UDI-Device Identifier: 15019315038808
• UDI-Public: 15019315038808
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 100/870/080
• Device Catalogue Number: 100/870/080
• Device Lot Number: 3227021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention