MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX NRFIT EPIDURAL NEEDLES, PORTEX NRFIT SPINAL; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number NCE6336JP

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 03/01/2020

Event Type  malfunction  

Event Description

It was reported that immediately upon use, the needle bent at the center and broke at the base.No patient injury was reported.

Manufacturer Narrative

A product sample was received for evaluation.Visual and functional testing were performed.An inspection of the sample confirmed that it was broken at a point about 2 millimeter (mm) from the base of the needle and bent at a point 40 millimeter (mm) from the tip.The reported event was confirmed; however, the root cause of the reported issue could not be determined.Samples were sent to the supplier for detailed investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Unique identifier are 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# (b)(4).

• Brand Name: PORTEX NRFIT EPIDURAL NEEDLES, PORTEX NRFIT SPINAL
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15321977
• MDR Text Key: 301099020
• Report Number: 3012307300-2022-16807
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: NCE6336JP
• Device Lot Number: 200212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 08/30/2022
• 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