MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/860/085
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device inserted to the patient by the doctor in the operating room was deflated after insertion.Subsequently, the device with which it was exchanged in the department by the doctor also had a cuff failure.No patient harm.A1: one patient, two product malfunctions.(b)(6) both represent the same patient.
Additional Manufacturer Narrative
Other, other text: d4: udi section is unknown; no information has been provided to date.G5: 510k is blank, this catalog number is not sold in the united states.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
Device evaluation: one device was returned for investigation.Under visual inspection we noticed a tear in cuff.Functional testing found that it is not even possible to inflate the cuff as it leaks so badly.Due to fact that cuff leak was not observed prior use, because there are visible signs of use, it is the most probable that reported failure occurred during tracheostomy procedure or during use due to contact with a sharp edge.Root cause was attributed to failure to follow instructions.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No actions taken.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (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: 18125095
• Report Number: 3012307300-2023-10482
• Device Sequence Number: 12710441
• Product Code: BTO
• UDI-Device Identifier: 15019517077940
• UDI-Public: (01)15019517077940(11)210329(17)260225(10)4110769
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2026
• Device Model Number: 100/860/085
• Device Catalogue Number: 100/860/085CZ
• Device Lot Number: 4110769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/20/2023; Not provided
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/18/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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