MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60NFPS35
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier, a2 - age at time of event, a2 - age units (patient), a2 - dob null, a3a - sex, a4 - weight, a4 - weight units (patient), a5 - ethnicity, and a6 - race: correction.
Additional Manufacturer Narrative
B3: unknown; no information has been provided 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 information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was stated that the parent was using the device and noticed that the flange was starting to split.There was no reported patient involvement.
Additional Manufacturer Narrative
D4 - lot #, expiration date, primary udi number: updated.D9 - date returned to mfg: 12/19/2025.H3 and h6 codes - updated.One used device was returned for investigation.The device was visually inspected and found a piece of one of the eyelets was observed to be missing.The deformation of the area showed a smooth clean half and a rough, uneven half.The complaint of flange starting to split cannot be confirmed.However, during investigation, a chunk of eyelet was observed to be missing.The probable cause is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23758350
• Report Number: 3012307300-2025-13320
• Device Sequence Number: 10105261
• Product Code: JOH
• UDI-Device Identifier: 15021312516692
• UDI-Public: (01)15021312516692(17)291031(10)6063302
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083641
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: 60NFPS35
• Device Lot Number: 6063302
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 02/23/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/11/2026; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Sex: Female
• Patient Weight: 9 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White