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

Model Number	100/897/090
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 "they place the uniperc which immediately leaks".(this product malfunction reported under (b)(6).They examine another one, which has a crack in it.There was patient involvement.No patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6 - evaluation codes: updated.Device evaluation: one used and decontaminated sample was returned for investigation.Under visual inspection the sample appeared to be in good condition.The inflation test was repeated on the received sample.It was found that sample cannot pass this 12 hour test - cuff was deflating during inflation.Source of leak was found to be tear in inflation lumen.The leak complaint was confirmed.No cracks or any signs of damage were observed.Due to fact that cuff leak was not observed prior use it is the most probable that reported failure occurred during tracheostomy procedure or during use due to contact with a sharp edge.No trend of similar customer complaints was identified.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.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucka 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18536475
• Report Number: 3011237704-2024-00018
• Device Sequence Number: 18085989
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: (01)15019315107214(17)251020(10)4013580
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 02/21/2024

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: 10/20/2025
• Device Model Number: 100/897/090
• Device Catalogue Number: 100/897/090CZ
• Device Lot Number: 4013580
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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