MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX SUCTION ABOVE CUFF ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/189/080
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 a hemostatic balloon catheter was inserted into the suction line above the cuff, it was confirmed that the catheter had poor suction at the top of the cuff.This occurred during infusion at the facility.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Evaluation codes: updated.At the time of this investigation the physical device was not received at the investigation site.Four photos were included for evaluation.According to the photos received, no issues were observed in the suction line.The complaint could not be confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Additional Manufacturer Narrative
D9: 11/13/2024.H6: updated.H3: one sample was received.Sample was visually inspected and it was found that the part arrived without reported cuff and necessary assembly.The customer reported complaint was able to be confirmed.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.

• Brand Name: PORTEX SUCTION ABOVE CUFF ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• 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: 19939436
• Report Number: 9617604-2024-00634
• Device Sequence Number: 7331900
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: (01)15019315059544(17)280815(10)4421893
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081086
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 100/189/080
• Device Lot Number: 4421893
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 09/09/2024; 04/21/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/07/2024; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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