MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX VENTILATION ACCESSORIES; CONNECTOR, AIRWAY (EXTENSION)

Model Number	66-1997
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).510k is unknown.No information has been provided to date.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.A product sample was received for evaluation.Visual and functional testing were performed.One sample was received.During the visual inspection, it was observed the sample was missing the patient connector.The root cause was related to the manufacturing process.Due to the low occurrence no action will be taken at this time.Complaints will continue to be monitored for any trends in incorrect assembly.
Event or Problem Description
It was reported that during the pre-use check, the customer noticed no patient-side connector came with it the product.No patient injury was reported.

• Brand Name: PORTEX VENTILATION ACCESSORIES
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• 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: 15674660
• Report Number: 3012307300-2022-26270
• Device Sequence Number: 20448801
• Product Code: BZA
• UDI-Device Identifier: 10788942619975
• UDI-Public: 10788942619975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Model Number: 66-1997
• Device Catalogue Number: 66-1997
• Device Lot Number: 3690134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• 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): 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