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

Catalog Number	100/897/070
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that after eight hours in use, a smiths medical uniperc adjustable flange tracheostomy had an insufficient seal.As a result, the tube was withdrawn and a new tube was inserted.A bulge was noted on the tube that was withdrawn.No adverse effects occurred,.
Additional Manufacturer Narrative
The tracheostomy (pvc - portex tubes pdt uniperc) did not return for investigation.The investigation was performed based on received photo because no sample was returned.According to the investigation on the photo there is one 007/842/070cz tube & flange assembly, cuffed, uniperc, 7mm with asymmetric cuff.The cuff defect might happen once the cuff is overinflated above values stated in instructions for use lls10001025 rev.100 point 8.12 (cuff pressures should be monitored and adjusted hourly with a purpose designed gauge or be monitored automatically.Cuff pressure should not exceed 30 cm water).The reported compliant confirmed that device the device was used outside of hospital which conflicts with the instructions for use lls10001025 rev.100 point 6.5: "this adjustable flange tracheostomy tube must not be used outside an area where its use can be closely monitored such as an intensive care unit or an intermediate care unit.It should be changed to a custom-made fixed flange tracheostomy tube prior to discharge form the hospital." the investigation confirmed that the customer reported problem was confirmed.However, based on results of investigation it is the most probable that the failure is a result of the customer/ user interfacing with the product in a manner inconsistent with the ifu.According to the investigation the problem source of the reported problem is user interface.

• Brand Name: SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY
• 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: 9336970
• Report Number: 3012307300-2019-06246
• Device Sequence Number: 1735034
• Product Code: BTO
• UDI-Device Identifier: 15019315060434
• UDI-Public: 15019315060434
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 01/13/2020

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: No Information
• Device Catalogue Number: 100/897/070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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