MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ENDOBRONCHIAL TUBE, 37 FRENCH; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Catalog Number 198-37L

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the white cuff inflated without any problem, but the white cuff pilot balloon would not inflate.There was patient involvement but no patient harm or adverse event was reported.

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.A product sample was received and is awaiting evaluation.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.

• Brand Name: PORTEX ENDOBRONCHIAL TUBE, 37 FRENCH
• Type of Device: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
• 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: 18902497
• MDR Text Key: 337649790
• Report Number: 9617604-2024-00230
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 15019315058622
• UDI-Public: (01)15019315058622(17)251008(10)4325778
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 198-37L
• Device Lot Number: 4325778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1