MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/080
Medical Device Problem Codes	Decrease in Pressure (1490); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received that a smiths medical portex uniperc adjustable flange tracheostomy tube had problems with the cuff holding pressure while in use with a patient.Twenty days after incretion, the tracheostomy (trach) tube was replaced with another smiths medical portex trach.Following the change out, it was discovered the initial trach pilot balloon and cuff appeared to be full of "water, fluid, and/or secretions." no adverse patient effects were reported.
Additional Manufacturer Narrative
One portex uniperc tracheostomy (trach) tube was returned for analysis in used conditions.Under visual inspection the trach tube appeared to be in good condition, no water / fluid was found in the pilot balloon and no tear in the cuff was noted.Inflation test was performed; no discrepancies found.Based on the evidence there was no fault found for the root cause as the complaint was not confirmed.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8011148
• Report Number: 3012307300-2018-01930
• Device Sequence Number: 1499022
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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 Catalogue Number: 100/897/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: 44 YR