MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ULTRA SUCTIONAID, ADULT, 8.0MM; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/860/080

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problems Dyspnea (1816); Respiratory Insufficiency (4462)

Event Date 03/19/2024

Event Type  Injury  

Event Description

It was reported that ¿the physician exchanged the patient's previous cannula for the cannula which presented the following issues.It was stated that the physician did not check the cannula before the procedure.The patient presented with respiratory distress, was foaming by the mouth, dyspneic and agitated.A technician, who was present at the house, reported that the tracheostomy balloon was not inflated, that she had already tried to inflate it, but it was not inflating; the balloon seemed to have a hole.¿ on the same day the patient presented the symptoms, and the defective cannula was removed and exchanged for a new one.The patient was stabilized at the hospital and cleared on the next day.No "field action" was taken by the facility regarding the affected product and that there was no other related occurrence which caused death or serious injury on the last two years.As per the report this adverse event was classified as ¿serious¿ by the reporter.

Manufacturer Narrative

H3 - other: device has not been returned to date.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.No trend of confirmed complaints in relation with this issue was identified.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID, ADULT, 8.0MM
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneaolis, MN 55442 ; 2247062300
• MDR Report Key: 19174826
• MDR Text Key: 340952594
• Report Number: 3012307300-2024-02980
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315104725
• UDI-Public: (01)15019315104725(17)281006(10)4431727
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/860/080
• Device Catalogue Number: 100/860/080CZ
• Device Lot Number: 4431727
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention