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

Catalog Number	100/133/060
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a nasal tracheal end probe was performed with balloon size 6.The balloon was pierced, probe removed (and thrown away), and installation of a second probe was performed.Again, there was observation of a pierced balloon.The second probe was kept (soiled).Three tubes were placed to allow the patient to be intubated.Installation of the third probe occurred without any problems encountered.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: one (1) used.List #100/133/060, tracheal tube maxillo facial n/nasal ivory s/sl cuff 6.0mm 10/bx; lot #4465624 was received for evaluation.Testing confirms the failure; inspection shows big size of damage in cuff.Considering the part arrived in a plastic bag after use, and from the big size of damage it is possible that the original packaging and cuff were inadvertently damaged during the opening process.This may indicate that the product was handled in a manner that led to damage by the end user.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX MAXILLOFACIAL ENDOTRACHEAL TUBE W/ CUFF
• 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: 20913545
• Report Number: 9617604-2024-00929
• Device Sequence Number: 12719007
• Product Code: BTR
• UDI-Device Identifier: 15019315020339
• UDI-Public: (01)15019315020339(17)290318(10)4465624
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K931735
• 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): 04/22/2025

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: 100/133/060
• Device Lot Number: 4465624
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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