MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; BREATHING CIRCUIT CIRCULATOR

Lot Number 4118159

Device Problem Gas/Air Leak (2946)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

It was reported that during pre-test, leakage of air from the breathing bag was detected.The customer did not use the product.No patient injury.No further information is available.

Manufacturer Narrative

Other text: additional information added to h6 and h10.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found sample presented damage/broken on the breathing bag.Functional testing confirmed the issue; sample was rejected by the leak test equipment due to damage / broken on the breathing bags.The root cause of the reported issue, based on the investigation results, there is leakage due to pinholes on the raw material breathing bag provided by the supplier.Actions were taken to mitigate the reported issue: corrective actions was addressed and implemented through supply notification.

• Brand Name: PORTEX
• Type of Device: BREATHING CIRCUIT CIRCULATOR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 12417944
• MDR Text Key: 269761038
• Report Number: 3012307300-2021-09119
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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 Lot Number: 4118159
• 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: 08/04/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1