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

Catalog Number	101/870/080CZ
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that water had accumulated inside the pilot balloon in a patient who had been using it continuously for about 2 months.When the tube was replaced, water also entered the cuff.This occurred during patient use/administration at facility.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 and h6.Codes: updated.Device evaluation: one used decontaminated sample was returned for investigation.Customer described that there was water inside the pilot balloon.Tracheostomy tube inflation system is dedicated for inflation of cuff by air.Therefore, it shall be leak proof.There are only two possible reasons for fluid inside inflation system - inflation system leak (e.G.Fluid can get into the inflation system through cuff tears or in pilot balloon) or incorrect practice during use which do not respect instructions for use (e.G.Cleaning of inflation system by a fluid/inflation line flushed by a liquid instead of suction line by error/etc.).Under visual inspection the sample appeared to be in good condition, no water inside cuff (inflation system) was found.An inflation test was performed and after twelve hours the cuff was still fully inflated.The device was also submerged in water.No air leak or fluid inside inflation system was observed.Based on the investigation results no fault with the returned sample was found.It is most probable that fluid was introduced into the inflation system due to a practice which is not in compliance with instructions for use.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE, CUFFED
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20833089
• Report Number: 3011237704-2024-00266
• Device Sequence Number: 11776895
• Product Code: BTO
• UDI-Device Identifier: 15019517076226
• UDI-Public: (01)15019517076226
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: Health Professional
• Device Catalogue Number: 101/870/080CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown