MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GAS SAMPLING LINE; GENERAL ANESTHESIA GAS SAMPLING

Catalog Number 225-3422-800

Device Problems Obstruction of Flow (2423); Blocked Connection (2888)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported that the instrument was found occluded during pre-testing.No patient injury or adverse effects were reported.

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.G5: 510k is unknown, no information available.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Device evaluation: one device was returned for investigation.Visual inspection found the tube was occluded.The complaint was confirmed.The root cause was attributed to being caused during the bonding of the luers operation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.All mitigations currently in place were verified and it was confirmed they have been executed accordingly.This issue will continue to be monitored for this failure condition in this product for threshold or escalation.

• Brand Name: PORTEX GAS SAMPLING LINE
• Type of Device: GENERAL ANESTHESIA GAS SAMPLING
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17289631
• MDR Text Key: 318938736
• Report Number: 3012307300-2023-07047
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225-3422-800
• Device Lot Number: 4288281
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1