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

Model Number	503060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that one week following placement of a smiths medical portex® cuffed d.I.C® tracheostomy tube, the cuff was found leaking.There were no reported adverse effects.
Additional Manufacturer Narrative
Device evaluation- one opened device was returned for evaluation.The visual examination of the device showed no abnormalities.The device cuff was inflated and then device was submerged under water to check for leakage.During the functional testing no leakage was identified.The reported issue could not be verified.

• Brand Name: PORTEX CUFFED D.I.C TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9782176
• Report Number: 3012307300-2020-01656
• Device Sequence Number: 18958679
• Product Code: BTR
• UDI-Device Identifier: 10351688017772
• UDI-Public: 10351688017772
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 503060
• Device Catalogue Number: 503060
• Device Lot Number: 3865679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1