MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX TUBES BLUSELECT SUCTIONAID; BAG, RESERVOIR

Catalog Number	101/870/070CZ
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tube cracked above the cuff suctionaid and was not able to suction the patient.There was a tracheostomy change.There was patient involvement, no patient injury was reported.
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.
Additional Manufacturer Narrative
D9: 08-jul-2025.H3: one device was received for evaluation in used condition.Four pictures were returned showing complaint forms and the sample in biohazard bag.As received, the suction line luer was observed to be wrapped in tape.Upon removal of the tape, no damage or anomalies were observed.Functional testing was performed, and a singular crack was found on the luer.The complaint of suction port being cracked can be confirmed.The probable cause of the crack is unknown.A lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: BAG, RESERVOIR
• 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: 22331343
• Report Number: 3012307300-2025-07686
• Device Sequence Number: 21191228
• Product Code: BTC
• UDI-Device Identifier: 15019517076202
• UDI-Public: (01)15019517076202(17)291025(10)6004213
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173384
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: Lay User/Patient
• Device Catalogue Number: 101/870/070CZ
• Device Lot Number: 6004213
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown