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

Catalog Number C37101329-NLJ

Device Problem Gas/Air Leak (2946)

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

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

Udi number, lot number and protocol # are unknown, no product information has been provided to date.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 the pre-use check, leakage of air from the product was observed (which caused an air leak alarm to be issued).No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updates not required.H10: 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.D10: device available for evaluation: yes.G4: date received by manufacturer: 11/09/2022.H3: device evaluated by manufacturer: device evaluation anticipated, but not yet begun, corrected data: d4: lot number: 4269436.D4: device expiration date: 01-jun-2025.H4: device manufacturing date: 02-jun-2022.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample and one (1) picture was received for evaluation.Visual and functional testing was performed.Visual inspection found no damages nor other workmanship defects were detected.Functional testing found the circuit was connected and successfully passed the test; thus, failure mode is not confirmed.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• 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; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 15807781
• MDR Text Key: 307561215
• Report Number: 3012307300-2022-27263
• 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: 06/13/2023

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 Catalogue Number: C37101329-NLJ
• Device Lot Number: 4269436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 06/07/2023
• Supplement Dates FDA Received: 12/01/2022; 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1