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

Model Number	100/860/090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: g5: 510k number 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.
Event or Problem Description
It was reported that while in use with a patient, the connector at the end of the suction line had come off.Adverse effects are unknown.
Additional Manufacturer Narrative
Email is: (b)(6).Evaluation codes: updated.Device evaluation: one device was received for investigation.Per visual inspection, it was detected that the connector is separated from the suction line.It was detected that the dried glue residue on the tip of the tube where the connector is connected was not uniform.The complaint was confirmed.Th condition could be caused by the tube not being submerged properly into the solvent dispenser or a dispenser with a low level of solvent.Root cause was attributed to manufacturing; a bonding issue.The lot number was not provided, therefore no device history report (dhr) review could be performed.A 7-minute talk was given to manufacturing personnel on awareness of the importance of carrying out the manufacturing process in a responsible and efficient manner.A 7-minute talk was given to quality inspection personnel to raise awareness of the importance of carrying out the inspection process in a responsible and efficient manner., corrected data: g5.
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: 18124119
• Report Number: 3012307300-2023-10465
• Device Sequence Number: 12691626
• Product Code: BTO
• UDI-Device Identifier: 15019517076172
• UDI-Public: (01)15019517076172(11)221213(17)271122(10)4285775
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• 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): 02/21/2024

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 Model Number: 100/860/090
• Device Catalogue Number: 100/860/090CZ
• Device Lot Number: 4285775
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/31/2023
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 02/21/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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