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

Catalog Number	100/386/010CZ
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the filter is faulty.It was reported that during dosing of a male patient, the study drug leaked at the connection point between the filter and the needle.The site did not report any ¿popping¿ sound when the filter was attached.An estimated 1.5 ml of study drug was lost; the patient was subsequently dosed with the remaining study drug in the syringe.The device was handled by a healthcare professional.There was patient involvement and no human harm.Associated complaint documented on (b)(4).
Additional Manufacturer Narrative
One used device was received for evaluation.Functional and visual testing were performed; however, the reported issue could not be duplicated.No damage or anomalies were observed in the as-received condition, and no leakage was identified.Each filter was subsequently leak tested using a hydrostatic pressure pump, and no leakage was observed.Therefore, the complaint of leakage could not be replicated or confirmed, and the root cause could not be determined.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• 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: 24434328
• Report Number: 3012307300-2026-01646
• Device Sequence Number: 10304486
• Product Code: BTO
• UDI-Device Identifier: 15019315107283
• UDI-Public: (01)15019315107283(17)280131(10)4344555
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 100/386/010CZ
• Device Lot Number: 4344555
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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
• Patient Sex: Unknown