MAUDE Adverse Event Report: ST PAUL PORTEX GENERAL ANESTHESIA CIRCUITS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Model# and pma/510k are unknown.No information is provided to date.Operator of device is unknown.Initial reporter also sent report to fda is unknown the sample in picture 1 corresponds to the breathing bag.The sample contains bag bushing, white vinyl tape and breathing bag.No root cause has to be determined since the complaint was not confirmed.No corrective actions are required since the complaint was not confirmed.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device packaging came with different bushing at the end of the breathing bag.No patient injury was reported.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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; minneapolis, MN 55442
• MDR Report Key: 15410457
• MDR Text Key: 305876530
• Report Number: 3012307300-2022-18919
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1