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

Model Number 101/860/080

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Unintended Deflation (4061)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, the customer intubated the product into the patient.Then on (b)(6) 2023 the pilot balloon was found inflated but the cuff was not.The patient had a lot of phlegm and blood phlegm was also seen.Normally the product was changed every two (2) weeks.Immediately after discovering this event, water droplets were also seen in the cuff.No additional information is available for this complaint.

Manufacturer Narrative

Lot number, expiration date and device manufacture date is unknown, no information has been provided to date.Device evaluation: one (1) decontaminated sample was returned for investigation.Under visual inspection the sample appeared to be in good condition.During the manufacturing process the devices are 100 percent 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.The inflation test was repeated on the received sample.It was confirmed that after 12 hours the cuff was still fully inflated.Based on the test results the reported failure was not observed.No trend of similar customer complaints was identified.A device history record (dhr) review could not be performed as the lot number for the device is not known.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16585554
• MDR Text Key: 311745917
• Report Number: 3012307300-2023-02815
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1