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

Catalog Number 670003

Device Problems Crack (1135); Leak/Splash (1354)

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.No product information has been provided to date.

Event Description

It was reported that during the pre-use air leak check of three devices, leakage was detected in all of them.Also, one (1) had a crack in the connector.No patient injury was reported.No additional information is available.

Manufacturer Narrative

Other, other text: no lot number was provided; therefore, device history record review could not be performed.Three (3) product samples and seven (7) pictures were received for evaluation.Visual and functional testing were performed.Visual inspection of the pictures observed a top view of 3 bags which is present tears and damaged on different sections.Visual inspection of the samples were torn.Functional testing found the failure reported could not be reproduced in the manufacturing process.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.Therefor the damage (broken) was after the product left manufacture facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

Manufacturer Narrative

Corrected data: there is no indication that the initial reporter submitted a report to the fda.(e4).

• 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: 15253379
• MDR Text Key: 305343259
• Report Number: 3012307300-2022-15616
• 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,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 670003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2022
• 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