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	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they place the uniperc which immediately leaks.They examine another one, which has a crack in it (this product malfunction reported under (b)(4).There was patient involvement.No patient harm/adverse event reported.Update: gcm received an email from kathrin kronlund on 19-dec-2023 in which states that there were 2 products involved with lot number 3986056 and lot number 4013580 and confirmed the pick-up address.Lholhos 19-dec-2023.
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.
Additional Manufacturer Narrative
H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One decontaminated device sample was received for investigation.Under visual inspection the sample appeared to be in good condition.No cracks or any signs of damage were observed.An inflation test was performed on the received sample.It was found that the cuff was deflating during inflation.The complaint was confirmed.The source of the leak was found to be a tear in inflation lumen.It was unknown what caused the tear.However, because a cuff leak was not observed prior use it is the most probable that the reported failure occurred during tracheostomy procedure or during use due to contact with a sharp edge.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No trend of similar customer complaints was identified.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18530019
• Report Number: 3011237704-2024-00017
• Device Sequence Number: 20757730
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: (01)15019315107214(17)250421(10)3986056
• 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): 02/20/2024

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: 04/21/2025
• Device Model Number: 100/897/090
• Device Catalogue Number: 100/897/090CZ
• Device Lot Number: 3986056
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/12/2024
• 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: 01/17/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• 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