MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® CUFFED D.I.C.® TRACHEOSTOMY TUBES; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	503070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One used device was returned for evaluation.Visual inspection of the device found stress marks at the opening of the one-way inflation valve and a crack within the wall of the housing of the valve.Functional testing involved a leak test and found signs of leakage at the crack in the one-way valve.It was suspected the stress was caused by repetitive use and excessive force.Based on the evidence, the root cause was unable to be confirmed.
Event or Problem Description
It was reported that a smiths medical device leaked after weeks of use.Due to the incident, an emergency tracheostomy tube change was required and the patient was placed on a ventilator.No injury was reported.The event was considered resolved.

• Brand Name: PORTEX® CUFFED D.I.C.® TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7041164
• Report Number: 3012307300-2017-02454
• Device Sequence Number: 1132975
• Product Code: BTR
• UDI-Device Identifier: 10351688009265
• UDI-Public: 10351688009265
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2021
• Device Catalogue Number: 503070
• Device Lot Number: 3260388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/17/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 78