MAUDE Adverse Event Report: ICU MEDICAL, INC PORTEX BLUE LINE ULTRA SUCTIONAID CUFFED TRACHEOSTOMY TUBE & INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/870/080CZ
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that incident of portex tracheostomy tube size 8.0 with above cuff suction aid found to be cracked and tube had to be replaced due to the fault, found during use on patient.Medication was not being used with this product.The product was not reprocessed or re-sterilized prior to use.There was patient use, with no patient injury.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
D1 & d2a: corrected.D3: mfg establishment name; icu medical, inc.Device evaluation: no product returned for device analysis; a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID CUFFED TRACHEOSTOMY TUBE & INNER CANNULA
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22319866
• Report Number: 3012307300-2025-07559
• Device Sequence Number: 8948607
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: (01)15019315104862(17)291025(10)6004213
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNKNOWN
• 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
• Report Date (Section B): 07/31/2025

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: 100/870/080CZ
• Device Lot Number: 6004213
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown