MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX MAXILLO FACIAL NASAL POLAR ENDOTRACHEAL TUB; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/065
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during manipulation the tube became pierced or punctured.This caused the balloon to non-inflate.Patient involvement is unknown.Additional information was requested; however, no further specific details on this incident were received.Item lot number is unknown.No patient injury or adverse affects were reported.
Additional Manufacturer Narrative
Other, other text: d4: lot number, expiration date, and h4: manufacture date are unknown, no information has been provided 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.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number was provided therefore no device history report (dhr) review could be completed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
D4: insufficient information was provided to be able to determine the full udi.Udi related data quality updates only.

• Brand Name: PORTEX MAXILLO FACIAL NASAL POLAR ENDOTRACHEAL TUB
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 18142252
• Report Number: 3012307300-2023-10512
• Device Sequence Number: 15092960
• Product Code: BTR
• UDI-Device Identifier: 15019315020346
• UDI-Public: 15019315020346
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 100/133/065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown