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 Consequences Or Impact To Patient (2199)

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 kagurazaka, shinjuku-ku; tokyo, 162-0 825; JA 162-0825
• MDR Report Key: 5915659
• MDR Text Key: 53567270
• Report Number: 1058382-2016-00001
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2016,08/30/2016

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 Operator: No Information
• 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
• Distributor Facility Aware Date: 08/26/2016
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1