MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SILICONIZED PVC ORAL/NASAL SOFT SEAL CUFF TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/166/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device was in use with patient.The reporter stated the device leaked air near the cuff connection.No adverse effects to patient reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The sample was in used conditions without its original packaging.No visual discrepancies were found.A syringe was used to inflate the cuff and suction line of the sample and was submerged under water in order to verify for leaks or discrepancies.Leakage was observed between the valve and pilot balloon.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.The root cause of the reported issue could not be confirmed during evaluation; however, the most probable root cause is that solvent was missing between pilot balloon and valve, and a lack of detection by the production personnel on the leak test area.Actions were taken to mitigate the reported issue: updates were made to the maintenance procedures to reference the correct parameters for the solvent dispenser.The supervisor and quality engineer retrained the manufacturing personnel on the appropriate procedure.

• Brand Name: PORTEX SILICONIZED PVC ORAL/NASAL SOFT SEAL CUFF TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer (Section G): NULL; ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7859892
• Report Number: 3012307300-2018-03844
• Device Sequence Number: 11080627
• Product Code: BTR
• UDI-Device Identifier: 15019315054082
• UDI-Public: 15019315054082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 02/28/2023
• Device Model Number: 100/166/070
• Device Catalogue Number: 100/166/070J
• Device Lot Number: 3565240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2018
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown