MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 100/491/718

Device Problems Break (1069); Fracture (1260)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.Visual inspection was performed.The two returned parts were inspected, and the investigator found nothing suspicious with the manufacturing of the returned parts.The investigator found out that the parts were damaged due to additional torque applied by the user.The root cause of the reported issue was determined to be related to the customer's impact to the device.A device history record (dhr) review was conducted, which indicated that all inspections were completed, and no issues were noted during manufacture.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).

Event Description

It was reported that the epidural connector broke during use.No patient injury was reported.

• Brand Name: CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES
• 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; chandigarh rd,near radha soami; minneapolis, MN 55442
• MDR Report Key: 15311438
• MDR Text Key: 305414114
• Report Number: 3012307300-2022-16512
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2022

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 100/491/718
• Device Lot Number: 3653423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1