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

Catalog Number 100/897/070

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Event 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in use, a smiths medical uniperc adjustable flange tracheostomy had an insufficient seal.As a result, the tube was withdrawn and a new tube was inserted.A bulge was noted on the tube that was withdrawn.No adverse effects occurred,.

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
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9336970
• MDR Text Key: 166851008
• Report Number: 3012307300-2019-06246
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315060434
• UDI-Public: 15019315060434
• Combination Product (y/n): N
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: 100/897/070
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention