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

Catalog Number	Z115-12
Medical Device Problem Codes	Complete Blockage (1094); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suction catheters stop suctioning as the blue stopper becomes detached and blocks flow.It happens especially when sputum secretions are thick and cannot be replicated with saline or thin secretions.There was patient involvement, but no patient harm/adverse event 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 reportable information becomes available.
Additional Manufacturer Narrative
Received two devices, visual inspection found no physical damage or other anomalies observed.Upon closer inspection, there were some dried-up residuals were observed in the set.Actuated the blue plunger with no evidence of the blue stopper becoming detached and blocking the flow.Customer complaint of the blue stopper becoming detached and blocking flow cannot be confirmed.

• Brand Name: PORTEX SUCTIONPRO CATHETER
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20347258
• Report Number: 9617604-2024-00771
• Device Sequence Number: 7805193
• Product Code: BSY
• UDI-Device Identifier: 15019315035395
• UDI-Public: (01)15019315035395
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: Z115-12
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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