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

Catalog Number C45041317J

Device Problem Product Quality Problem (1506)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and is awaiting evaluation and 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.Lot number, udi number and pma/510k are unknown, no product information has been provided to date.

Event Description

It was reported that during the pre-use check, the customer noticed the length of the breathing circuit on the inhalation end differed from that on the exhalation end.No patient injury.No additional information is available.

Manufacturer Narrative

H10: device evaluation: one sample was returned for investigation.The returned sample was received in used condition without original packaging.The sample was visually inspected under normal conditions of illumination to detect any condition that could cause the failure mode reported.The samples present marks of manipulation.Samples were fully extended and measured using a ruler.Both couple of tubes for each sample present variation, as well length is under the criteria established.Based on the analysis conducted in the sample provided, variation on length of tubes as failure mode was confirmed.Therefore, the occurrence of this failure condition could be caused due to detection failure during the manufacturing process.For corrective action, an awareness complaint notification to the production personnel was conducted by quality engineer for the defect reported by the customer.A device history record (dhr) could not be performed in that no specific product was identified.No serial number was provided.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15275938
• MDR Text Key: 305167433
• Report Number: 3012307300-2022-15837
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

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: C45041317J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1