MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD2 SAFETY NEEDLE; TERUMO NEOLUS NEEDLE

Catalog Number 102-N2558S

Device Problem Use of Device Problem (1670)

Patient Problems Needle Stick/Puncture (2462); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The user facility reported that a clinician incurred a needle stick while trying to engage the safety sheath feature.Follow-up communication with the user facility confirmed; clinician was attempting to activate the safety mechanism by pushing her thumb on the safety mechanism; the syringe shifted and the needle picked her finger; the device did not lock; blood diagnostics were performed per their internal procedures and results were clean; the procedure was complete; and there was no patient involvement.

Manufacturer Narrative

The investigation has yet to be completed.A follow-up report will be submitted when the investigation is complete.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

Manufacturer Narrative

This follow-up report #3 is being submitted to provide the date the manufacturing facility received additional information regarding the event and/or evaluation of the actual sample.This date was inadvertently omitted in the previous follow-up report.The information provided below lists the date(s) the additional information was received by the manufacturing facility: follow-up #1 = 7/17/2014.

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).The involved device is not available for evaluation.Current lot and retained samples from the reported lot were inspected.No abnormalities or defects were noted on visual inspection and all samples passed functional testing.A review of the device history record confirmed that there were no production related problems for this lot number.There is no indication that the event was related to a pre-existing device defect.The device labeling does address the potential for such an occurrence in the instructions-for-use with statements such as the following: (1) "position the sheath approximately 45 degrees to flat surface"; (2) "press down with a firm, quick, motion until a distinct audible click is heard"; (3) "visually confirm that the needle is fully engaged under the lock"; and (4) "dispose of used needles and materials following the policies and procedures of your facility as well as federal and local regulations for sharps disposal." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending, and follow-up.

Event Description

This report is being submitted as follow-up #1 for mfg.Report 3003902955-2014-00011 to provide additional information provided by the user facility.

Manufacturer Narrative

(b)(4).

Event Description

(b)(4).

• Brand Name: SURGUARD2 SAFETY NEEDLE
• Type of Device: TERUMO NEOLUS NEEDLE
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna MD 21921 ; RP 21921
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna MD 21921 ; RP 21921
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 3940483
• MDR Text Key: 4573540
• Report Number: 3003902955-2014-00011
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2014,07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102-N2558S
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2014
• Date Manufacturer Received: 10/23/2014
• 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: Initial
• Patient Sequence Number: 1