MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number CA24E0/4K2/004JP

Device Problem Obstruction of Flow (2423)

Patient Problems Decreased Respiratory Rate (2485); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluation 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.No lot or serial numbers were communicated; device expiration date and device manufacturing date not available.Udi#: unknown.

Event Description

It was reported that during the use of the product, the gas sampling line was found constricted (narrowed).No patient injury was reported.

Manufacturer Narrative

Other, other text: one device was returned for investigation.A clear substance that appeared to be clogged was found in the lumen of the connection between the connector and the tubing.The reported event was confirmed.The sample was forwarded to another site for additional root cause analysis.Issue may be related to a supplied item fault.The lot number has not been provided, therefor the device history review could not be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required., corrected data: h6 problem patient code: code corrected, 4582 incorrect.

Manufacturer Narrative

Other, other text: device was returned for investigation along with a couple photos.The photos showed where the device occlusion was suspected.Visual inspection of the device showed excessive solvent in the distal end of the gas sampling tube and male luer connector joint.A functional test was done where it was further confirmed that the flow was occluded by the excessive solvent.The manufacturing team was made aware of this and monitoring will be done.No device history review able to be done as no lot number was provided.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• 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; 7-1-1 akasaka; minneapolis, MN 55442
• MDR Report Key: 16121552
• MDR Text Key: 306907079
• Report Number: 3012307300-2023-00244
• Device Sequence Number: 1
• Product Code: CAI
• 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,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CA24E0/4K2/004JP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening