MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ENDOTRACHEAL TUBES SACETT

Catalog Number	100/189/075
Medical Device Problem Codes	Device Alarm System (1012); Decrease in Pressure (1490); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device has not yet been returned for investigation.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 the patient had a ventilator low tidal volume alarm at 9:25.The doctor was informed that the air bag pressure was estimated to be 22cmh2o, and it was immediately inflated to 32cmh2o.After calibration, the ventilator low tidal volume alarm occurred again at 9:27.The air bag pressure was 24cmh2o and the air bag was suspected to have a leakage.The endotracheal intubation was replaced at 9:30.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4: udi updated.H6: evaluation codes updated.Device evaluation: no sample was returned for this complaint.Photos were not provided to confirm the reported failure mode.Testing was not conducted for the investigation.If the product is returned at a later date, the complaint will be reopened for further investigation.No non-conformances were found during the dhr review.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SACETT
• Common Device Name: TRACHEAL TUBE
• 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: 18451621
• Report Number: 9617604-2024-00013
• Device Sequence Number: 15368834
• Product Code: BTR
• UDI-Device Identifier: 15019315059537
• UDI-Public: (01)15019315059537(17)270722(10)4264597
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 4264597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown