MAUDE Adverse Event Report: ST PAUL PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 100/594/000

Device Problem Connection Problem (2900)

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

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.The returned sample was found defective, since the edge of the device did not reach the limits after applying 3.5 kg force.The root cause was related to a supplier issue.Inspection level for the device was increased from normal to tightened during previous complaints and no similar defects have been reported after implementation of corrective actions.Twenty pieces of a current lot available in warehouse were inspected and the samples were found accepted.It was considered that corrective actions taken with previous complaints were adequate to mitigate the reported failure mode.A device history record (dhr) review could not be performed as the lot number was 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# 617147.

Event Description

It was reported that during a pre-use check, the user attempted to connect the device to a tracheostomy tube, but was unable to because of a connection failure; and therefore, the device was not used.No patient injury was reported.

• Brand Name: PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• 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; 2-12-12 kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 15362356
• MDR Text Key: 305706777
• Report Number: 3012307300-2022-17923
• Device Sequence Number: 1
• Product Code: BZA
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 100/594/000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1