MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	450952-NL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the procedure the corrugated tube was found to be disconnected from the patient-side y-site connector.No patient injury was reported.
Additional Manufacturer Narrative
Operator of device is unknown.No information has been provided to date.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.The sample was received in used condition without original packaging.Visual inspection confirmed the device was disassembled.A capa was opened to investigate this issue.Unable to determine the root cause of the reported issue.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-21-2 motohama-cho, naka-ku,; minneapolis, MN 55442
• MDR Report Key: 15437096
• Report Number: 3012307300-2022-19412
• Device Sequence Number: 5594500
• Product Code: CAH
• UDI-Device Identifier: 15019315075834
• UDI-Public: 15019315075834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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
• Device Model Number: 450952-NL
• Device Catalogue Number: 450952-NL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 09/16/2022
• 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