MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	11-1010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
Event or Problem Description
It was reported that a dose inhaler detached from the base at the connection to the ventilation circuit making it difficult to use.No patient injury was reported.

• Brand Name: PORTEX
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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: 15409667
• Report Number: 3012307300-2022-18869
• Device Sequence Number: 20211887
• Product Code: CAF
• UDI-Device Identifier: 10788942110106
• UDI-Public: 10788942110106
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K953206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare 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 Expiration Date: 04/16/2024
• Device Model Number: 11-1010
• Device Catalogue Number: 11-1010
• Device Lot Number: 3794780
• 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: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• 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 Sex: Unknown