MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TUBE SECUREMENT ENDOTRACHEAL; SUPPORT, BREATHING TUBE

Catalog Number	100/503/200JP
Medical Device Problem Codes	Disconnection (1171); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event day unknown.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 velcro on the tube holder comes off, and the rubber part stretches.This causes the tracheotomy tube to come out.Among 37 tracheostomy patients, 20 used ventilators.Tube holders were changed weekly, with gauze placed between the tube and neck.Many patients had heavy secretions.In one case, the tracheostomy tube came out due to the rubber part stretching, and in another, the tube holder became wet, causing the velcro to come off.This occurred during patient use, during infusion.There was no patient harm/adverse event reported.
Additional Manufacturer Narrative
B5: event description corrected.G2: corrected.H6: corrected.This report is to document the rubber stretching on the device.Another report (-----) was submitted to document the holder becoming wet causing the velcro to come off.
Event or Problem Description
It was reported that the velcro on the tube holder comes off, and the rubber part stretches.This causes the tracheotomy tube to come out.Among 37 tracheostomy patients, 20 used ventilators.Tube holders were changed weekly, with gauze placed between the tube and neck.Many patients had heavy secretions.In one case, the tracheostomy tube came out due to the rubber part stretching, and in another, the tube holder became wet, causing the velcro to come off.This occurred during patient use, during infusion.There was no patient harm/adverse event reported.This report is to document the rubber stretching on the device.Another report (-----) was submitted to document the holder becoming wet causing the velcro to come off.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: the customer reported issue of the velcro on the tube holder comes off, and the rubber part stretches¿ was confirmed during visual inspection.The cause was unknown, and the returned product was sent to the supplier for evaluation.A device history record (dhr) review could not be performed as the lot number was unknown.Additionally, the item is a purchased finished good, manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.

• Brand Name: PORTEX TUBE SECUREMENT ENDOTRACHEAL
• Common Device Name: SUPPORT, BREATHING TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21786658
• Report Number: 3012307300-2025-03866
• Device Sequence Number: 8692415
• Product Code: JAY
• UDI-Device Identifier: 15019315031823
• UDI-Public: (01)15019315031823
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2025

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 Catalogue Number: 100/503/200JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 05/20/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 04/09/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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