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

Model Number	62.002.0079.4244/711CRSA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing device history record review was not performed because manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.A product sample was received for evaluation.Visual inspection was performed.Visual inspection found the gas sampling port was broken at the base of the housing.The root cause of the reported issue was found to be component failure - supplied item fault.The sample will be sent to the supplier.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.
Event or Problem Description
It was reported that during the pre-use check, the sampling port was found broken (damaged) from the base.No patient injury was reported.No additional information is available for this complaint.

• Brand Name: PORTEX BACTERIAL VIRAL FILTER
• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15262233
• Report Number: 3012307300-2022-15712
• Device Sequence Number: 20270129
• Product Code: CAH
• UDI-Device Identifier: 15019315083297
• UDI-Public: 15019315083297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: 11/01/2025
• Device Model Number: 62.002.0079.4244/711CRSA
• Device Catalogue Number: 2874
• Device Lot Number: LT2011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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