MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX TUBES PDT UNIPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/070
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2: death date is unknown.Device evaluation: 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 information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported that the device became displaced following surgical insertion in one of the icu patients.The mechanism/'clip' used to secure the tracheostomy tube itself to the flange caused a potential safety concern.The tracheostomy was mistakenly inserted upside down, with the "clip" facing upwards.This resulted in it becoming knocked open when the patient was moved.The tracheostomy became displaced and the patient rapidly desaturated difficulties replacing it through a fresh stoma.The tracheostomy became displaced the morning after it was surgically placed on (b)(6) 2025.It was also difficult to re-intubate her, but surgical assistance was on hand to place a small (size 6) endotracheal tube through the tracheostomy stoma prior to it being formally replaced in theatre.The patient subsequently died but her death was not directly related to the displaced tracheostomy.The status of the event is resolved.There was patient involvement and adverse harm reported.
Additional Manufacturer Narrative
B2: date of death unknown.H3: no device or device photo was returned for investigation.Although the complaint mentions a photo, only a catalogue image was provided, not a photo of the actual used product.Due to this, no root cause was determined.The device history review of the reported lot number was not possible as no lot number was provided.If the product is returned, this complaint will be reopened for further investigation.The customer also had reported a potential issue related to the flange locking mechanism.However, it was also stated that the product was inserted incorrectly, which is the most likely root cause of the reported incident.It was further noted that the tracheostomy displacement was not considered to be the direct cause of the patient's death.

• Brand Name: PORTEX TUBES PDT UNIPERC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22554746
• Report Number: 3012307300-2025-08620
• Device Sequence Number: 9647036
• Product Code: BTO
• UDI-Device Identifier: 15019315060434
• UDI-Public: (01)15019315060434
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/15/2025

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: 100/897/070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Age: 25 YR
• Patient Sex: Unknown
• Patient Weight: 160 KG