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

Catalog Number	101/860/100CZ
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.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 cuff did not inflate.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: one sample was received.Under visual inspection the sample appeared to be in good condition.The inflation test was repeated on the received sample.It was found that the cuff was leaking.A hole was found.Due to the fact that the cuff leak was not observed prior to use it is the most probable that the reported failure occurred during the tracheostomy procedure or during use due to contact with a sharp edge.No trend of similar customer complaints was identified.No lot history review was performed because no lot number provided.

• Brand Name: PORTEX SUCTIONAID CUFFED 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20340089
• Report Number: 3011237704-2024-00206
• Device Sequence Number: 8062583
• Product Code: BTO
• UDI-Device Identifier: 15019517076189
• UDI-Public: (01)15019517076189
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• 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): 11/07/2024

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 Catalogue Number: 101/860/100CZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/07/2024
• 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