MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EZPAP AIRWAY THERAPY SYSTEMS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	23-0757
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after receiving the products, in the package included a pressure gauge, which is normally not included with this product.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).A review of the device history records showed there was one nonconformance was reported as noted in the analysis details.No product sample was received; therefore, visual and functional testing could not be performed.The investigation of this complaint was done based on photo.The customer requested part 23-0757.Part 23-0757 was sent however the label on the bag identified part as 23-0747.The root cause was related to manufacturing choosing the incorrect label format.No action will be taken at this time as there is no risk and the incident was confined to the reported lot number.

• Brand Name: PORTEX EZPAP AIRWAY THERAPY SYSTEMS
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15674516
• Report Number: 3012307300-2022-26267
• Device Sequence Number: 6407001
• Product Code: BWF
• UDI-Device Identifier: 10788942207578
• UDI-Public: 10788942207578
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K991300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

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 Expiration Date: 07/01/2022
• Device Model Number: 23-0757
• Device Catalogue Number: 23-0757
• Device Lot Number: 3627062
• 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: 09/29/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• 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