MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/561/090
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tracheostomy tube that is purple, is the wrong size and does not protrude from the tracheostomy tube.It was therefore impossible to insert the tube.There was patient involvement, but no patient harm.
Additional Manufacturer Narrative
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.

• Brand Name: BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25482878
• Report Number: 3012307300-2026-06004
• Device Sequence Number: 13244355
• Product Code: JOH
• UDI-Device Identifier: 15019517103380
• UDI-Public: (01)15019517103380(17)290201(10)6175781
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173912
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: 101/561/090
• Device Lot Number: 6175781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• 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