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

Model Number 66-1997

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2019

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307030358
• Report Number: 3012307300-2022-26270
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 10788942619975
• UDI-Public: 10788942619975
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1