MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SACETT SUCTION ABOVE CUFF ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/189/075
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was tested prior to intubating patient for cuff leaks and passed.Once the patient was intubated the cuff would not hold air or pressure.The patient required this tube to be removed and replaced.No adverse patient effects were reported by the customer.
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.
Additional Manufacturer Narrative
One returned sample was received in used condition without the original packaging.Visual inspection revealed there was a hole in the cuff.The reported deflated cuff problem was confirmed.This type of hole 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, damage was caused.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 (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: PORTEX SACETT SUCTION ABOVE CUFF ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• 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: 18107383
• Report Number: 3012307300-2023-10427
• Device Sequence Number: 12151714
• Product Code: BTR
• UDI-Device Identifier: 15019315059537
• UDI-Public: (01)15019315059537(11)230724(17)080701(10)4403637
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100/189/075
• Device Catalogue Number: 100/189/075
• Device Lot Number: 4403637
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/31/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 02/21/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown