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

Catalog Number	100/897/090
Medical Device Problem Codes	Leak/Splash (1354); Decrease in Pressure (1490); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Hypoxia (1918); Low Oxygen Saturation (2477)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that three weeks following placement of a smiths medical portex® uniperc® adjustable flange tracheostomy tube the cuff was reported to be not maintaining pressure.Air was added to the cuff but the following day, the cuff had deflated causing the patient's oxygen saturation decline.Subsequently, a trach tube change out was performed and the patient recovered.There were no further reported adverse effects.
Additional Manufacturer Narrative
One adjustable flange tracheostomy tube was returned for analysis in used condition.Visual inspection revealed no discrepancies.Inflation test performed on the sample and a cuff leak was observed.A cuff tear was noted after further examination.Based on the evidence, the complaint was confirmed with most probably cause being user interface.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8895414
• Report Number: 3012307300-2019-04191
• Device Sequence Number: 16236147
• Product Code: BTO
• UDI-Device Identifier: 15019315060458
• UDI-Public: 15019315060458
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 100/897/090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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: Life Threatening; Required Intervention