MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	505070
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One tracheostomy device was received for evaluation.Evaluation of the provided sample found size 7.0 mm, decontaminated, cuffed flexible d.I.C, tracheostomy device without original package and 10 ml plastic syringe.The device arrived with deflated cuff.The customer also provided photos of inflated devices.While the device analysis could not be performed based on provided photos, the returned sample was visually evaluated and no visible non-conformities were observed.The measurements were taken for proper cuff positioning on the tube.The cuff was found to be positioned in accordance with the specification.In the complaints details, the customer indicated that the "cuff slid down the shaft and partially occluded the tube causing high pressures and inability to pass the suction catheter".The customer also indicated that the devices had been placed a few weeks ago.The cuff of the returned device was inflated and visually inspected.The cuff was found to be symmetrical with tube and not twisted.The airway of the tube was not obstructed by the inflated cuff.The tube airways of the trach devices on customer's photos were not obstructed either.The reported event could not be confirmed or replicated.Root cause was not able to be determined as the reported event was unable to be determined.A dhr review could not be completed as no lot number was provided.
Event or Problem Description
It was reported that the cuff on the tube appears to have slid down the shaft and partially occluded the tube, causing high pressures, and inability to pass the suction catheter.The trach tube was replaced to resolve the reported event.
Additional Manufacturer Narrative
One tracheostomy device was received for evaluation.Evaluation of the provided sample found size 7.0 mm, decontaminated, cuffed flexible d.I.C, tracheostomy device without original package and 10 ml plastic syringe.The device arrived with deflated cuff.The customer also provided photos of inflated devices.While the device analysis could not be performed based on provided photos, the returned sample was visually evaluated and no visible non-conformities were observed.The measurements were taken for proper cuff positioning on the tube.The cuff was found to be positioned in accordance with the specification.In the complaints details, the customer indicated that the "cuff slid down the shaft and partially occluded the tube causing high pressures and inability to pass the suction catheter".The customer also indicated that the devices had been placed a few weeks ago.The cuff of the returned device was inflated and visually inspected.The cuff was found to be symmetrical with tube and not twisted.The airway of the tube was not obstructed by the inflated cuff.The tube airways of the trach devices on customer's photos were not obstructed either.The reported event could not be confirmed or replicated.Root cause was not able to be determined as the reported event was unable to be determined.A dhr review could not be completed as no lot number was provided.
Event or Problem Description
It was reported that the cuff on the tube appears to have slid down the shaft and partially occluded the tube, causing high pressures, and inability to pass the suction catheter.The trach tube was replaced to resolve the reported event.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13471770
• Report Number: 3012307300-2022-02780
• Device Sequence Number: 11734121
• Product Code: BTR
• UDI-Device Identifier: 10351688000231
• UDI-Public: 10351688000231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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
• Device Model Number: 505070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• 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: 09/10/2021
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 37 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White