MAUDE Adverse Event Report: NULL PORTEX NRFIT EPIDURAL NEEDLES; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number NSE4200CJP

Device Problem Separation Problem (4043)

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

Event Date 09/01/2020

Event Type  malfunction  

Event Description

It was reported that during use of the device, the user noticed the epidural needle was easily disconnected from a syringe (including a loss-of-resistance syringe).No patient injury was reported.

Manufacturer Narrative

A syringe was returned to perform an investigation.A visual inspection of the sample found no abnormality.To confirm the function, the combined strength of the nrfit male connector of the returned syringe and a non-defective syringe were measured using an iso standard gauge.No difference in the strength of the returned product and the non-defective product were found.It was possible that there was a problem with the connector on the epidural needle side; however, no abnormality was found with the returned syringe.No root cause could be determined as the complaint could not be confirmed.A device history record (dhr) review was not performed as the lot number was unknown.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX NRFIT EPIDURAL NEEDLES
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section G): NULL
• MDR Report Key: 15326713
• MDR Text Key: 305372869
• Report Number: 3012307300-2022-16931
• Device Sequence Number: 1
• Product Code: BSP
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: NSE4200CJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• 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