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

Catalog Number	100/189/075
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pilot balloon deflated while during patient reanimation.There was patient involvement and unknown patient harm.
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
Investigation summary: one returned sample received was in used condition and in a plastic bag.The sample was visually inspected at 12¿ to 16¿ and normal conditions of illumination according to the inspection procedure md01-003.During visual inspection the cuff stuck to the tube was observed.The pilot balloon issue was not confirmed.

• Brand Name: PORTEX SACETT, SUCTION ABOVE CUFF TRACHEAL
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19561774
• Report Number: 9617604-2024-00533
• Device Sequence Number: 7483280
• Product Code: BTR
• UDI-Device Identifier: 15019315059537
• UDI-Public: (01)15019315059537(17)280112(10)4347892
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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 Catalogue Number: 100/189/075
• Device Lot Number: 4347892
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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