MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ENDOBRONCHIAL TUBES; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Model Number	198-37L
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: 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 upon opening, there was a "lack of accessories".Connector part was not included.No patient injury or clinical affects was reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer and h6.Evaluation codes: updated.Email is: regulatory.Responses@icumed.Com.One device sample was received in used condition with the original packaging opened.Two photos were included for evaluation; photos showed the complaint sample.It was reported that the packaging was missing a connector but did not specify what type of connector was missing.The customer returned a used sample with open packaging without any of the product accessories.Per visual inspection, only the endobronchial tube was identified.The complaint was confirmed.No other analysis was performed.The root cause could not be identified.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Based on the analysis performed, the reported missing/incorrect component was confirmed.The sample was returned used and opened from the package, the complete product was not returned and all the accessories (connectors) of the product were identified as missing, that is why it could not be determined which connector was missing, the customer did not specify which connector was missing in the packaging, the root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from the assembly process.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: PORTEX ENDOBRONCHIAL TUBES
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18187700
• Report Number: 3012307300-2023-10707
• Device Sequence Number: 6503864
• Product Code: CBI
• UDI-Device Identifier: 15019315058622
• UDI-Public: (01)15019315058622(11)221013(17)250921(10)4325769
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2024

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 Expiration Date: 09/21/2025
• Device Model Number: 198-37L
• Device Catalogue Number: 198-37L---802
• Device Lot Number: 4325769
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/22/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown