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

Catalog Number 100/597/080CZ

Device Problems Leak/Splash (1354); Decrease in Pressure (1490)

Patient Problem Respiratory Failure (2484)

Event Date 03/22/2019

Event Type  Injury  

Event Description

It was reported that there was a lack of pressure in the cuff and difficulty in achieving the mechanical ventilation.After removal of the cannula, the leak test was carried out and a leak at the level of the connection between the cannula and inflation device was detected.The patient was obese and was affected by acute respiratory failure and required prolonged ventilation as a result.The tracheostomy and the cannula had been in use for 80 minutes before the defect was observed.No further complications were reported in relation to this event.

Manufacturer Narrative

Device evaluation : one uniperc sample was received for evaluation in used condition and without its original packaging.Upon immediate visual inspection, it was found that the cuff burst.However, this defect happened during decontamination by smiths medical and will be excluded from investigation.It was also noted that the inflation lumen on tracheostomy tube is punctured in place where inflation line is connected with lumen.This issue can occur when the adjustable flange is over pulled above the last marking on the tube (close to 15mm connector), which is in conflict with instruction for use.The device instruction describes the following: "using the "initial flange settings" table above and the skin to anterior tracheal wall thickness estimated at stage 11.4, as a guide, adjust the tracheostomy tube flange (patient side) using the 10mm graduations on the tracheostomy tube to its correct length and lock the flange firmly in position by pushing the blue locking arm downwards until it is flush with the white flange hub." additionally, during manufacturing process, the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.Furthermore, the device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Based on the evidence and testing, the complaint was confirmed.User interface was noted as the problem source as the issue was observed after placement.The most probable cause of the reported failure occurred during tracheostomy procedure due to contact with sharp edges, also in conflict with instruction for use to "guard against cuff damage by avoiding contact with sharp edges.".

• Brand Name: PORTEX TUBES PDT UNIPERC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8714373
• MDR Text Key: 148515461
• Report Number: 3012307300-2019-03625
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107146
• UDI-Public: 15019315107146
• Combination Product (y/n): N
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 100/597/080CZ
• Device Lot Number: 3434840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention