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

Catalog Number	100/133/060
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.D5.Other operator of device: operator of device is unknown.E1.Initial reporter phone#: (b)(6).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.
Event or Problem Description
It was reported that during the dental list they encountered a problem with the size six nasal tubes.Once inserted the balloons deflated on four separate tubes, three of which came from the same lot.There was patient involvement and unknown patient harm/adverse event reported.This complaint was created to capture the 1st of 4 related incidents.
Additional Manufacturer Narrative
H6.Evaluation codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORTEX MAXILLOFACIAL ENDOTRACHEAL TUBE CUFFED
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18660616
• Report Number: 9617604-2024-00105
• Device Sequence Number: 8063626
• Product Code: BTR
• UDI-Device Identifier: 15019315020339
• UDI-Public: 15019315020339
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: Other
• Device Catalogue Number: 100/133/060
• Device Lot Number: 4386937
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/18/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown