MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ENDOTRACHEAL TUBE M/EYE UNCUFFED SILICONISED ORAL/NASAL; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/141/030
Medical Device Problem Codes	Defective Device (2588); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 phone: ext 72178 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 products appear to feature a smaller diameter than previously.Every 3.0 ett used since february has been affected.Normally the 8fr suction fits easily through the 3.0 ett; however, with use in current products, they will not advance beyond 14cm.Hospital is now having to use smaller suction catheters than standard care ¿ changed inline suction catheter to a 6 french.Rt have located older product within the hospital and confirmed older product has no issue with diameter size.There was patient involvement (2events).Outcome- increased leak around ett and 8fr suction catheter changed to 6 fr to sxn.It caused extra intubation.Two events were reported (emdr-19934 and emdr-20613).This is the first malfunction for the related reports.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.Device sample was received in used condition with the pouch open inside a plastic bag.During visual inspection, no visual defects were found.An occlusion test was performed, and the device failed.The complaint was confirmed as the device dimension was out of specification.The complaint fault has been escalated to address a full root cause investigation.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 ENDOTRACHEAL TUBE M/EYE UNCUFFED SILICONISED ORAL/NASAL
• Common Device Name: TUBE, TRACHEOSTOMY (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: 19202519
• Report Number: 9617604-2024-00360
• Device Sequence Number: 12750664
• Product Code: BTR
• UDI-Device Identifier: 15019315019036
• UDI-Public: (01)15019315019036(17)280322(10)4380611
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790312
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 100/141/030
• Device Lot Number: 4380611
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 893 KG