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

Catalog Number C45091342-NLJ

Device Problems Defective Device (2588); Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event is unknown; no information has been provided to date.G5: 150k is blank, the device product code is 510k exempt.D3, g1,2 email is: (b)(4).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.

Event Description

It was reported that during a pre-use check, the "rx circuit's flexible tube has not shrunk as much as before (black mark)", and there was a leak.Device is returning.No patient injury or clinical affects was reported.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT, EXPANDABLE
• 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
• Manufacturer Contact: reed covert
• MDR Report Key: 18288019
• MDR Text Key: 330019757
• Report Number: 3012307300-2023-10971
• 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
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45091342-NLJ
• Device Lot Number: 4347795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1