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

Model Number	100/585/000
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product was missing the barcode.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).The device history record (dhr) review is at supplier.No product sample was received; therefore, visual and functional testing could not be performed.The investigation of this complaint was done based on photo.Picture received showed portions of the barcode were missing and the printing quality was poor.The product is no longer produced at supplier, no supplier notification sent.The root cause was related to the supplier labelling process.No further action will be taken.

• Brand Name: PORTEX THERMOVENT HME SYSTEMS
• 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; no 678 gubei road; minneapolis, MN 55442
• MDR Report Key: 15668536
• Report Number: 3012307300-2022-26166
• Device Sequence Number: 17766572
• Product Code: CAH
• UDI-Device Identifier: 15019315083440
• UDI-Public: 15019315083440
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: 100/585/000
• Device Catalogue Number: 100/585/000
• Device Lot Number: 5651937
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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