MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX SP72 SINGLE LUMEN SUCTIONPRO; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Catalog Number	Z110N-14---802
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device port was torn.There was no patient involvement.
Additional Manufacturer Narrative
One photograph of the device was recieved for investigation.The reported issue was confirmed in the photograph, which demonstrated the reported tear in the device.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Based on the results of the evaluation, the reported issue was confirmed, but a root cause could not be established.Trend information will continue to be monitored.

• Brand Name: PORTEX SP72 SINGLE LUMEN SUCTIONPRO
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21326557
• Report Number: 9617604-2025-00104
• Device Sequence Number: 20799780
• Product Code: BSY
• UDI-Device Identifier: 15019315058868
• UDI-Public: (01)15019315058868(17)251206(10)4330282
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: Other
• Device Expiration Date: 12/06/2025
• Device Catalogue Number: Z110N-14---802
• Device Lot Number: 4330282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown