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

Catalog Number C37101307J

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Only the month ((b)(6)) and year (2020) of the event date are known.Customer facility phone number: (b)(6).Company representative phone number: (b)(6).Device evaluation in progress.

Event Description

It was reported that the portex general anesthesia circuit failed a pre-use air check.There was no patient involvement.

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

Other text: pictures were received along with six used samples of breathing circuits.The samples were visually inspected at a distance of 12 inches from the unit under normal lighting.No damage was detected on the samples.Functional testing was performed using a leak test.Two samples were tested.Sample one passed the leak test and sample two did not pass the leak test.The reported problem was confirmed.The most probable root cause was that connectors were not assembled correctly in manufacturing.Notification to production personnel regarding this malfunction was conducted by a quality engineer.D4 udi, d5, and g5 are unknown.No information has been provided to date.Additional information d3, d4 expiration date, e2, e3, g3 and h4.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; 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: 10938337
• MDR Text Key: 219311446
• Report Number: 3012307300-2020-12048
• 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: 09/20/2022

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 Expiration Date: 05/03/2023
• Device Catalogue Number: C37101307J
• Device Lot Number: 3973608
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/26/2020; 01/10/2022
• Supplement Dates FDA Received: 01/26/2021; 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1