MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. RESPIRONICS PR VALVE; CUFF, TRACHEAL TUBE, INFLATABLE

Model Number	292004
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the green pressure indicator was missing.No patient injury was reported.
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.One (1) opened part in a plastic bag with no lot identification, was received for investigation purpose.Complaint was confirmed since the part does not show the green strip on the piston.The root cause of the reported issue was found to be related to incorrect product handling during painting process and/ or incorrect segregation of material due to lack of inspection and details in procedures.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: RESPIRONICS PR VALVE
• Common Device Name: CUFF, TRACHEAL TUBE, INFLATABLE
• 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: 15353696
• Report Number: 3012307300-2022-17593
• Device Sequence Number: 6192965
• Product Code: BSK
• UDI-Device Identifier: 10351688517173
• UDI-Public: 10351688517173
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K833327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care 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 Model Number: 292004
• Device Catalogue Number: 292004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Is the Reporter a Health Professional?: Yes
• 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
• 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