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

Model Number 62.002.0079.4244/711CRSA

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 305251069
• Report Number: 3012307300-2022-15712
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 15019315083297
• UDI-Public: 15019315083297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1