MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. SUCTIONPRO 72; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Catalog Number	Z110-14
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that when liquid is injected into the device nozzle nothing reaches the patient.All the liquid flows onto the patient.Given the problem with the product it was necessary to disconnect the patient from the ventilation circuit in order to make the installation effective.This caused de-saturation and loss of expiratory pressure in the patient's lungs.There was patient involvement but no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: one (1) sample was returned in unused condition in its original packaging.One (1) video was also provided by the customer and reviewed.The sample was visually inspected under normal conditions of illumination to detect any cosmetic issue.No damage, cuts or discrepancies affecting its performance were found in the sample received.Sample was placed in the sleeve leak test to check the assembly for leaks.The device passes the leak test.Sample was placed in the valve leak tester to check the assembly for leaks.The valve was activated with the thumb valve body at different times to ensure that all components were present and activated correctly.The device passed the valve leak.The customer's reported failure was not confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: SUCTIONPRO 72
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20139922
• Report Number: 9617604-2024-00695
• Device Sequence Number: 7417036
• Product Code: BSY
• UDI-Device Identifier: 15019315034237
• UDI-Public: (01)15019315034237(17)250404(10)4258981
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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 Expiration Date: 04/04/2025
• Device Catalogue Number: Z110-14
• Device Lot Number: 4258981
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/18/2024
• 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