MAUDE Adverse Event Report: ST PAUL CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 100/491/718

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/03/2021

Event Type  malfunction  

Event Description

It was reported that upon use, the rotating luer lock of the filter disconnected.No patient injury was reported.

Manufacturer Narrative

The device was received to perform an investigation.A visual inspection of the returned product found no issues related to the reported problem.It was not possible to conduct liquid flow test as the component had been used.A device history record (dhr) review found no observations in relation to the reported issue.As no issues were found with the received device, no root cause could be determined.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).

• Brand Name: CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• 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: 15299567
• MDR Text Key: 305282357
• Report Number: 3012307300-2022-16301
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/491/718
• Device Lot Number: 3959490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2020
• 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