MAUDE Adverse Event Report: DR. JAPAN CO., LTD. RELI QUINCKE POINT SPINAL NEEDLE

Catalog Number SN25G351

Device Problem Difficult to Remove (1528)

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

Event Date 08/26/2016

Event Type  malfunction  

Event Description

It was reported the needle stylet (wire) was difficult to remove from needle hub during a cervical transforaminal lumbar block procedure.The clinician stated the extra force needed to remove the stylet from the needle hub made the needle difficult to control.No harm came to the patient and there were no adverse effects reported as part of the complainant follow-up.

• Brand Name: RELI QUINCKE POINT SPINAL NEEDLE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): DR. JAPAN CO., LTD.; 1-1 kagurzazaka, shinjuku-ku; tokyo, 162-0 825; JA 162-0825
• Manufacturer (Section G): DR. JAPAN CO LTD.; 1-1 kagurazaka, shinjuku-ku; toyko, 162-0 825; JA 162-0825
• Manufacturer Contact: hayayo hyugaji ; 1-1 kagarazaka; shinjuku-ku; tokyo, 162-0-825 ; JA 162-0825
• MDR Report Key: 6001936
• MDR Text Key: 233113454
• Report Number: 9614709-2016-00001
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2016

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 Expiration Date: 12/28/2020
• Device Catalogue Number: SN25G351
• Device Lot Number: 60101AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2015
• 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