MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SUCTIONPRO 72; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	Z110N-14
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the respiratory aide found that a part from the inline suction system was missing in the package.This was noticed immediately upon use.No patient injury was reported.
Additional Manufacturer Narrative
No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was performed, and no issues were noted during manufacture.No root cause could be determined as the complaint could not be confirmed.Operator of device is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: SUCTIONPRO 72
• 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: 15468982
• Report Number: 3012307300-2022-20162
• Device Sequence Number: 14569865
• Product Code: BSY
• UDI-Device Identifier: 15019315058868
• UDI-Public: 15019315058868
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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: 02/17/2021
• Device Model Number: Z110N-14
• Device Catalogue Number: Z110N-14
• Device Lot Number: 3592781
• 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: 07/10/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2018
• 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