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

Model Number SN22G351

Device Problems Difficult to Remove (1528); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 233113504
• Report Number: 9614709-2017-00001
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00386120006758
• UDI-Public: 00386120006758
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1