MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX UNIPERC ADJUSTABLE FLANGE CUFFED, 9.0 MM; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/897/090
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Codes	Ventilator Dependent (2395); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 - other: device has not been returned 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
The report stated that the tracheostomy cuff was not holding pressure on a ventilated patient.Urgent tracheostomy change required.The balloon failure was noted on wed evening and cuff pressures were monitored closely overnight and adjusted regularly- at times requiring 1/2 hourly checks.The outcome of the faulty balloon is that the patient required ventilation for longer than normal as it was not as effective as normal.The tracheostomy change was planned for thursday or an emergency change would have been organized.It lasted for 24 days.Normally the changes are planned for 28 days.The schedule had not been adjusted after the emergency change at the beginning of feb as in the next "riskman".There was patient involvement but no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9: date returned to mfg.: 4/15/2024.H3 and h6.Evaluation codes: updated.One decontaminated device sample inside the tube was returned.Under visual inspection the sample appeared to be in good condition.A functional leak test was performed, and it was found that sample cannot pass the test - cuff was deflating.The source of the leak was found to be tear in inflation lumen.Because the 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 or incorrect manipulation with flange.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 and there were no other customer complaint against the reported lot number.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE CUFFED, 9.0 MM
• 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: 18995667
• Report Number: 3011237704-2024-00075
• Device Sequence Number: 12647150
• Product Code: BTO
• UDI-Device Identifier: 15019315060458
• UDI-Public: (01)15019315060458(17)271101(10)4285756
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083031
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 100/897/090
• Device Catalogue Number: 100/897/090CZ
• Device Lot Number: 4285756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male