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

Catalog Number 100/563/090

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This kit contains a cannula with subglottic suction which was issued to the lot as per the requirements in the custom move order pick list.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed the returned sample was received in used conditions without its original packaging.Customer's reported issue was not confirmed.This kit does contain a cannula with subglottic suction.The instructions for use which is packaged with the kit also detail that the kit contains a cannula with subglottic suction.The root cause of the reported issue was not determined.The correct cannula was included in the kit.Actions taken to mitigate the reported.No corrective action was taken.Udi information is unknown.Premarket (510k) number is unknown.

Event Description

It was reported that sets contained the wrong tracheostomy tube.No patient injury reported.

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (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: 15685505
• MDR Text Key: 307029131
• Report Number: 3012307300-2022-26389
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/563/090
• Device Lot Number: 3760328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1