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

Model Number 62.002.0079.4244/711CRSA

Device Problem Inadequate Filtration Process (2308)

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

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the filter absorbed a large amount of water.No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

Other, other text: the device was returned.It was observed that the blue sponge of the artificial nose contained water.The root cause was undetermined.The reported issue was confirmed.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.(updated h6), corrected data: in the initial report, h3 and h5 were answered incorrectly.

• Brand Name: PORTEX RESPIRATORY FILTERS
• 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 14427709
• MDR Text Key: 291959024
• Report Number: 3012307300-2022-08949
• 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,Followup
• Report Date: 09/08/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1