MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	Z115-12
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received for evaluation.Visual and functional testing were performed.No visual defects were observed.It was inspected that each catheter has enough silicon (not excessive) so that it slides through the wiper seal easily and wiper seal does not pull out.Suction-pro valve is operational and is not damaged, after the valve assembly toggle press.No visual defects were observed.Functional tests were performed.All tests were successfully; no leak test or other failure mode was confirmed.There is no root cause for this event since the failure mode reported could not be confirmed in site.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that catheter was twisted causing discomfort to patient when suctioning.No patient injury reported.

• Brand Name: PORTEX
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15353850
• Report Number: 3012307300-2022-17659
• Device Sequence Number: 5825615
• Product Code: BSY
• UDI-Device Identifier: 15019315035395
• UDI-Public: 15019315035395
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K923559
• 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): 09/03/2022

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: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: Z115-12
• Device Catalogue Number: Z115-12
• Device Lot Number: 3979366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown