MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX SUCTIONPRO CATHETER; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Catalog Number	Z210-14---802
Medical Device Problem Codes	Use of Device Problem (1670); Suction Problem (2170)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/19/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient's oxygen saturation was low, and they had thick mucus/phlegm that needed to be sanctioned, but the inline catheter was only able to move about 1 inch (where lumens attach to t-piece connector), and the patient continued to desaturate due to this issue.Reporter stated a new inline suction catheter was used and able to clear the sputum.The patient's oxygen saturation stabilized after.
Additional Manufacturer Narrative
D9: date returned to mfg.: 9/2/2025.D3: mfg establishment name, h3 and h6.Codes: updated.Device evaluation: received one (1) use product sample.Per visual inspection, as received, there were thick unknown residuals (mucus) in the tubing.Per functional testing, attached the returned suction set to the house vacuum, flow was established, however there were heavy residuals being purged from the set.Unable to confirm the complaint of unable to suction from patient's endotracheal tube.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX SUCTIONPRO CATHETER
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• 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: 22938968
• Report Number: 3012307300-2025-10235
• Device Sequence Number: 21274315
• Product Code: BSY
• UDI-Device Identifier: 15019315046902
• UDI-Public: (01)15019315046902(17)280225(10)6067100
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: Health Professional
• Device Catalogue Number: Z210-14---802
• Device Lot Number: 6067100
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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