MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX PERCUTANEOUS DILATION TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/597/090CZ
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the purple guide tube was difficult and occasionally unable to be inserted into the tracheostomy tube.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: one decontaminated device sample was received for investigation.Under visual inspection the sample appeared to be in good condition.The tracheostomy kit contains sterile lubricating jelly.The introducer shall be lubricated by the help of lubricant for better insertion.As per instruction for use ¿insert the lubricated introducer into the lubricated tracheostomy tube ensuring that it ¿clicks¿ into position.¿ testing was performed and the purple introducer was easy to insert into the tube.Based on results of testing the reported failure was not observed, and no trend of similar customer complaints was identified.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: PORTEX PERCUTANEOUS DILATION TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20183593
• Report Number: 3011237704-2024-00181
• Device Sequence Number: 21065662
• Product Code: BTO
• UDI-Device Identifier: 15019315107153
• UDI-Public: (01)15019315107153
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 100/597/090CZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown