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

Catalog Number 100/860/080CZ

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

It was reported that the cuff won't inflate.No patient injury was reported.

Manufacturer Narrative

A product sample was received for evaluation.Visual and functional testing were performed.Under visual inspection the sample appeared to be in good condition.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.The inflation test was repeated on the received sample.It was observed that it is not even possible to inflate cuff because it leaks so badly.The sample was put under microscope and app.0.8mm long tear in cuff was observed.The reported issue was confirmed.The most probable root cause is that this defect occurred during manufacturing of this device.Actions will be implemented with purpose to reduce the possibility of cuff damage after inflation test.Operator of device is unknown.Pma/510k is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15445292
• MDR Text Key: 306332235
• Report Number: 3012307300-2022-19603
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 100/860/080CZ
• Device Lot Number: 3869482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 09/19/2022
• 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