MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX MAXILLO FACIAL NASAL SOFT SEAL CUFF TRACHEOSTOMY TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/070
Medical Device Problem Codes	Inflation Problem (1310); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the device lost pressure upon inflation of the cuff.Non-reflux valve in the reservoir was failing.The user got 2 more size 7.0mm tubes.The first tube did fail, prior to insertion.The second tube held fast.It was the staff noticed immediately that the cuff deflated.The event occurred on (b)(6) 2023.There was a delay in therapy.There was patient involvement and no patient harm/adverse event reported.One bag was "contaminated" as it was inserted in a patient's airway prior to discovering the issue.The other was not "contaminated", but as it was transported in the same bag.The customer states that the treatment of both bags as "contaminated"."the tubes have all come from the same batch.".
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.Two device samples were received in used condition, in a plastic bag.During visual inspection no damage or other defects were detected on the samples.Both devices were leak tested and one sample did not pass the test and the other one passed.To identify the leak in the failed device, the sample was inflated with the use of a syringe, then submerged under water, where the leak was identified in the cuff.Based on the analysis performed on the samples, the failure mode of ¿valve issue¿ was not confirmed and the failure mode of ¿cuff deflation / leakage¿ and ¿cuff loses pressure¿ was confirmed.One of the samples has a tear on the cuff.This type of tear can be caused when the cuff inflated is in contact with some sharp edge, the unit is observed used, it seems that it got stuck during the intubation process and when pulling the device caused this leak.However, root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken as the complaint was not caused from manufacturing.

• Brand Name: PORTEX MAXILLO FACIAL NASAL SOFT SEAL CUFF TRACHEOSTOMY TUBE
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18527567
• Report Number: 9617604-2024-00055
• Device Sequence Number: 20436068
• Product Code: BTR
• UDI-Device Identifier: 15019315020353
• UDI-Public: (01)15019315020353(17)280410(10)4386932
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 100/133/070
• Device Lot Number: 4386932
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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