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

Model Number	101/562/000
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use test the distal portion of the device did not connect completely to the introducer.No patient injury or involvement was reported.
Additional Manufacturer Narrative
One sample received from decontamination without its original packaging.Confirmed that no such difficulties were observed when inserted both inner cannulas into tracheostomy tube.Introducer was also smoothly inserted into tracheostomy tube when a small amount of lubricating jelly was applied as described in instruction for use (ifu).Based on above investigation and functional testing we were not able to confirm the defect reported by customer.A device history record (dhr) review was not performed as no fault was found.No information has been received to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX TUBES PDT BLUPERC
• Common Device Name: 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: 15409674
• Report Number: 3012307300-2022-18872
• Device Sequence Number: 5620841
• Product Code: BTO
• UDI-Device Identifier: 15019517103397
• UDI-Public: 15019517103397
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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: 101/562/000
• Device Catalogue Number: 101/562/000
• Device Lot Number: 3951189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• 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: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown