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

Device Problem Leak/Splash (1354)

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

Event Date 02/05/2020

Event Type  malfunction  

Event Description

It was reported that a 1mm tear was found in the device during a pre-use air leak check.No patient injury was reported.

Manufacturer Narrative

The sample was received in used conditions without its original packaging.The breathing bag have a tear.No lot number was provided; therefore, device history record review could not be completed.Operator of device is unknown.Udi and protocol # are unknown.No information is 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 BAGS
• 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; fukushima, fukushima-ku, osaka; minneapolis, MN 55442
• MDR Report Key: 15446011
• MDR Text Key: 306003337
• Report Number: 3012307300-2022-19621
• Device Sequence Number: 1
• Product Code: BTO
• 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
• Report Date: 09/19/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2022
• Initial Date FDA Received: 09/19/2022
• 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