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

Catalog Number	100/189/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 - other: device has not been returned to date.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 after visual inspection, the cuff was inflated and visually checked for leaks.After insertion, it was noted that the patient's parameters were not good.A new endotracheal tube was used from the same lot.After the failure of 3 cuffs, an 8mm endotracheal tube one size larger was tested.This showed no air leak and was eventually placed on the patient.The patient was intubated several times.There was no report of patient harm/adverse event.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: the reported complaint was unable to be confirmed as no sample was returned and no photos were provided.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 in the dhr review.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SACETT
• 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: 18586273
• Report Number: 9617604-2024-00082
• Device Sequence Number: 15576333
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: (01)15019315059520(17)270601(10)4177258
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 100/189/070
• Device Lot Number: 4177258
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown