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

Model Number	SN22G351
Medical Device Problem Codes	Difficult to Remove (1528); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.
Additional Manufacturer Narrative
The manufacturer (dr.Japan) will investigate the event reported in this mdr report; however, the reported defective device was not returned to the manufacturer for evaluation.An update to this report will be provided if additional information is received from the customer to support the investigation of this event and/or upon the conclusion of the manufacturer's investigation.The following information was corrected and/or added to the blocks within this mdr follow-up report: 1.The manufacturer (dr.Japan) report number is being added as this follow-up report is considered the manufaturer's filing.2.Reference d5: the 'operator of device' information was inadvertently not selected during the initial submission of this event; block corrected.3.Reference g1-g5, g7: manufacturer's information added to this section as this follow-up report is considered the manufacturer's filing.4.Reference h1 - h6, h8: information added about the device reported to support the manufacturer's filing of this mdr report.
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, 162-0 852; JA 162-0852
• Manufacturer (Section G): DR. JAPAN CO. LTD; 1-1 karurazaka, shinjuku-ku; tokyo, 162-0 825; JA 162-0825
• Manufacturer Contact: hayayo hyugaji ; 1-1 karurazaka, shinjuku-ku; tokyo ; 0335138766
• MDR Report Key: 6499986
• Report Number: 9614709-2017-00001
• Device Sequence Number: 934233
• Product Code: BSP
• UDI-Device Identifier: 00386120006758
• UDI-Public: 00386120006758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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: Health Professional
• Device Expiration Date: 01/26/2021
• Device Model Number: SN22G351
• Device Catalogue Number: SN22G351
• Device Lot Number: 60201AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 04/18/2017
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown