MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL MINIPACKS; REGIONAL ANESTHESIA TRAYS

Catalog Number 100/391/118CZ

Device Problems Break (1069); Material Separation (1562)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.Visual inspection found that the rotating collar (lock) was missing on returned filter.The root cause of the reported issue was found to be retention edge on return sample was damaged and therefore it could not hold rotating collar in place.Information for use (ifu), precautions section, overtightening the connection between the epidural catheter connector or epidural needle to the male rotating collar may cause the rotating collar to dislodge from the filter body.A device history review (dhr) was not conducted as this was not considered a manufacturing issue.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that the filter tip on the epidural side broke off and separated from the catheter.No patient injury was reported.

• Brand Name: PORTEX EPIDURAL MINIPACKS
• Type of Device: REGIONAL ANESTHESIA TRAYS
• 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: 15316004
• MDR Text Key: 305386998
• Report Number: 3012307300-2022-16600
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/391/118CZ
• Device Lot Number: 4050194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Is the Reporter a Health Professional?: Yes
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female