MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CONTINUOUS TRAYS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

It was reported that the luer locking mechanism on the epidural filter had came off the filter and loosing connection to the epifuse connector.No patient injury reported.

Manufacturer Narrative

Catalog number is unknown.Udi information is unknown.Premarket (510k) number is unknown no lot number was provided; therefore, device history record review could not be completed.Samples were received for investigation in plastic bag without its original packaging.After visual inspection, it was noticed that luer lock connector is separated from filter body.Each flat filter have retention ring which is designed to hold luer lock connected with filter.Retention ring on the sample which was returned was found to be without any damage.Luer lock connector was found to be without any damage as well.The reported event of detachment of luer lock connector from filter body.Complaint samples which were historically received had damaged retention ring or luer lock connector which indicates supplier investigation outcome (over tightening).Based on complaint description customers believe that they do not use excessive force.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• 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: 15322356
• MDR Text Key: 304696342
• Report Number: 3012307300-2022-16827
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• 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