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

Catalog Number	SN22G351
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the stylet of the needle is sticking; being difficult to remove from the needle hub with the use of one hand.

• Brand Name: RELI QUINCKE POINT SPINAL NEEDLE
• Common Device Name: SPINAL NEEDLE
• Manufacturer (Section D): DR. JAPAN CO. LTD.; 1-1 kagurazaka, shinjuku-ku; tokyo, 162-0 825; JA 162-0825
• MDR Report Key: 6423799
• Report Number: 1058382-2017-00003
• Device Sequence Number: 13728723
• Product Code: BSP
• UDI-Device Identifier: 00386120006758
• UDI-Public: 00386120006758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2017
• Report Date (Section F): 03/22/2017

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
• Operator of Device: No Information
• Device Expiration Date: 01/26/2021
• Device Catalogue Number: SN22G351
• Device Lot Number: 60201AV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/08/2017
• Device Age: 13 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/22/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/22/2017