MAUDE Adverse Event Report: DR. JAPAN CO. LTD. SELECT; SPINAL NEEDLE

Catalog Number PSSSN22G351

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

The defect device was not returned to the factory for evaluation.At this time the lot number of the device is not available, so our investigation ability will be limited.If the device is returned or additional details become available regarding lot information, we will investigate accordingly.If additional information becomes available, we will submit a follow up report to include the corrected data.

Event Description

It was reported that the needle was sticking.There is little detail beyond the report but it is assumed the customer is referring to the needle stylet being difficult to pull out of the needle hub.No defect device has been returned for evaluation, and there was no adverse event associated with this report.

Manufacturer Narrative

The manufacturer, dr.Japan was notified of the complaint reported.Due to the customer failing to provide the lot number for this reported event, the manufacturer could not conduct an appropriate investigation of the reported device.Although the defective device was not available for the manufacturer to examine, the listed root cause was conveyed by the manufacturer for this event: root cause: a repair was made to the plunger (stylet) mold of the device in the area of the rib by the contract manufacturer.The resulting mold dimension of the plunger (stylet) rib was too big (an excess of material ws removed).This caused the fit between the plunger (stylet) and the needle hub.Corrective action: the mold of the plunger (stylet) rib was replaced and resulted in a looser fit between the plunger (stylet) and the needle hub.The following were corrected within this mdr follow-up report: operator of device - information was inadvertently omitted during the initial reporting of this event.The address of the importer ((b)(4)) has been updated from (b)(4) to (b)(4) to reflect the importer's new location.Follow-up choice selected in this field to update this report as a follow-up #001.Date received by manufacturer field updated to reflect the current date of 04/18/2017 for this follow-up report being sent to the manufacturer.'correction' and 'additional information' selected to describe this type of follow-up report being submitted here.(b)(4) added to capture additional device code associated with the reported malfunction.Based off the manufacturer's root cause and corrective action provided, we are moving to close the complaint file and consider this mdr closed.

Event Description

It was reported that the needle was sticking.There is little detail beyond the report but it is assumed the customer is referring to the needle stylet being difficult to pull out of the needle hub.No defect device has been returned for evaluation, and there was no adverse event associated with this report.

• Brand Name: SELECT
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): DR. JAPAN CO. LTD.; 1-1 kagurazaka, shinjuku-ku; tokyo, 162-0 825; JA 162-0825
• Manufacturer (Section G): DR. JAPAN CO. LTD.; 1-1 kagurazaka, shinjuku-ku; tokyo, 162-0 825; JA 162-0825
• Manufacturer Contact: hayayo hyugaji ; 1-1 kagurazaka; shinjuku-ku; tokyo, 162-0-825 ; JA 162-0825 ; 5138766
• MDR Report Key: 6001993
• MDR Text Key: 57057766
• Report Number: 9614709-2016-00002
• 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,Followup
• Report Date: 10/05/2016

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: Physician
• Device Catalogue Number: PSSSN22G351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2016
• Distributor Facility Aware Date: 09/23/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/27/2016
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2017
• 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