MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX PERCUTANEOUS DILATION TRACHEOSTOMY (PDT) KIT, 8MM; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/597/080
Medical Device Problem Codes	Deflation Problem (1149); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H4.Device mfg date: the reported lot# 4362786 could not be found for the reported catalog# 100/597/080 in the icu medical system; therefore, the manufacturing date could not be determined.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.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.
Event or Problem Description
It was reported that the balloon cuff on the tracheostomy tube was leaking.Frequent top-up's of air required to maintain seal of cuff.It was realized the balloon cuff had a faulty valve.When the valve was secured with a smart-site there was no further deflation of the balloon.There was patient involvement, and no patient harm/adverse event reported.

• Brand Name: PORTEX PERCUTANEOUS DILATION TRACHEOSTOMY (PDT) KIT, 8MM
• 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: 21037139
• Report Number: 3011237704-2024-00279
• Device Sequence Number: 8594750
• Product Code: BTO
• UDI-Device Identifier: 15019315060298
• UDI-Public: (01)15019315060298(17)251201(10)4362786
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

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 Expiration Date: 12/01/2025
• Device Catalogue Number: 100/597/080
• Device Lot Number: 4362786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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