MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/563/080
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the writing on pilot balloon rubbed off, unable to see size or cuff pressure.The event discovered while the tracheostomy tube was still in-situ (patient was transferred to the ward from icu and issue was noted when admitted to the trache team).There was patient involvement but no injury/harm.
Additional Manufacturer Narrative
Two used decontaminated samples were returned for investigation without the original packaging.The complaint was confirmed during visual inspection.During manufacturing each pilot balloon is one-hundred percent visual checked as per work instruction.Ensure ¿soft seal¿ is present on pilot balloon and the cuff-resting diameter is correct.Detection mechanism is in place, and it is improbable that the part with the writing rubbed off would pass through this inspection.It is most improbable that the failure was caused by the customer due to use or cleaning (e.G.Excessive force during cleaning, aggressive cleaner).No trend of confirmed complaints in relation to this issue was identified.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 20559277
• Report Number: 3011237704-2024-00230
• Device Sequence Number: 3103280
• Product Code: JOH
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410(17)261110(10)4408604
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (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): 10/29/2024

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: 101/563/080
• Device Lot Number: 4408604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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