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

Catalog Number CA32K0/000/000JP

Device Problem Obstruction of Flow (2423)

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

Event Type  Injury  

Event Description

It was reported that during the use of the product, an occlusion in the breathing circuit was found, which did not allow the customer to perform a ventilation properly.No patient injury was reported.

Manufacturer Narrative

Based on the leak test results the nonconformance reported as improperly ventilation is not confirmed, however base on the visual inspection the nonconformance as inner blue crushed is confirmed.Based on the investigation results the issue reported is confirmed as supplier issue.Third investigation was opened to our supplier quality (b)(4).Dhr: suspected lots 4105933 / 4138384 were manufactured with (b)(4) units, lots met the requirements to release with no deviations identified during their manufactured.

Manufacturer Narrative

Other, other text: additional information added to h6 and h10.This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.

• Brand Name: PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU
• 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; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 13502223
• MDR Text Key: 288492417
• Report Number: 3012307300-2022-03091
• 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: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA32K0/000/000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• 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
• Patient Outcome(s): Required Intervention