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

Model Number 101/812/070

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Other, other text: h4-device manufacture date unknown.D4-udi number unknown/expiration date unknown/lot number unknown.B3: date of event, no information has been provided to date.Device evaluation: no device was returned for investigation.No root cause able to be determined.Device history review could not be completed due to no lot number being provided.

Event Description

It was reported that the fenestrations in the inner cannula broke when the patient was cleaning it after one week of use.A new trach was received and broke in the same way during cleaning.No harm to the patient as both instances broke while cleaning.Additionally, the attachment used to pull the cannula broke as well.This is to document the second instance of the cannula breaking.The first instance is documented in (b)(4).

Event Description

Additional information received: no harm to the patient.Description from the patient: the patient has had a tracheostomy for 21 years.She has always cleaned the cannula herself, first rinse and then used a cleaning brush (as included in the package for the trachea).She tried to do it much more gently the second time, but the same happened again.She cleans the holes, where mucus collects easily.She has also been using a trachi swab which she can use if necessary.Size l.This is because the mucus is difficult to remove.She has been told by the hospital to use nacl and hydrogen peroxide for cleaning.No lot number available.Catalog number has been updated.Regarding the information received about cleaning the inner cannula: more information regarding the trachi swab has been requested.Patient has been informed that they must not use hydrogen peroxide for cleaning.I have also informed them that they must follow the cleaning instructions given in the ifu.

• 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: 17167209
• MDR Text Key: 317769755
• Report Number: 3012307300-2023-06416
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101/812/070
• Device Catalogue Number: 101/812/070CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1