MAUDE Adverse Event Report: ST PAUL PORTEX GENERAL ANESTHESIA CIRCUITS; DISPOSABLE BREATHING CIRCUITS

Lot Number 201106

Device Problem Leak/Splash (1354)

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

Event Date 02/01/2021

Event Type  malfunction  

Event Description

It was reported that during a pre-use check, leakage of air from the product was detected.No patient injury was reported.

Manufacturer Narrative

Other, a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The breathing circuit and the breathing bag were returned.As a result of observing the sample, no noticeable abnormality was observed.When a leak test of the breathing circuit was performed, the pressure did not rise and a leak was confirmed.When the breathing circuit was submerged in water, air leaks from scratches on the circuit were confirmed.No leaks were detected in the anesthesia bag.The reported event was confirmed.The root cause may be due to manufacturing.D4, d5 and g5 are unknown.No product information has been provided to date.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: DISPOSABLE BREATHING CIRCUITS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; sapporo city, hokkaido; minneapolis, MN 55442
• MDR Report Key: 15426748
• MDR Text Key: 299988426
• Report Number: 3012307300-2022-19220
• Device Sequence Number: 1
• Product Code: BTL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 201106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1