MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD3 SAFETY HYPODERMIC NEEDLE; TERUMO NEOLUS NEEDLE

Catalog Number SG3-03L2525

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

The involved device was not returned for evaluation, which limits the failure investigation to assessment of user facility information and evaluation of reserve samples from the reported lot and current lot samples.No abnormalities or defects were noted on visual inspection and all samples passed functional testing.Simulation testing was performed; retention samples were manually activated as per instructions for use (ifu), by finder activation, thumb activation, and surface activation.Audible sound (click) was heard and the needle was completely engaged under the tooth upon visual confirmation.Successful activation was achieved without breaking the safety sheath and no difficulty were experienced.A review of the device history records and inspection records indicated that there were no production related problems.Although the cause of the reported event cannot be definitively determined based upon the available information, there is no evidence that this event was related to a device defect or malfunction.The device labeling does address the potential for such an occurrence in the warnings/cautions and the instructions-for-use with statements such as the following: (1) after the injection procedure, use a one-handed technique to activate the safety mechanism using any of the three methods; finger activation, thumb activation, or surface activation.Activation is verified by an audible and/or tactile "click", and visually confirm that the safety sheath is fully engaged.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).Device not returned.

Event Description

The user facility reported that the sg3 safety guard is difficult to engage.

Manufacturer Narrative

This report is being submitted as follow-up #1 for mfg.Report # 3003902955-2014-00023 to provide the results of the evaluation of the ten unopened samples returned to the manufacturing facility.Ten unopened samples from the initially reported lot#/product code combination were returned to the manufacturing facility for evaluation.Visual inspection confirmed the following: 1) the collar, safety sheath and the sheath tooth of actual and retention samples were free from molding related defects: (2) the safety sheath was properly attached on the assemble needle and the collar was fully seated on the hub; (3) the safety sheath was properly attached on the assembled needle and the color was fully seated on the hub, which indicates the sheath was in normal alignment.Function testing confirmed that performance specifications were met.Simulation testing was conducted.Actual samples were manually activated as per instructions for use (ifu), by (c) finger activation, (d) thumb activation and (e) surface activation.Audible sound (click) was heard and the needle was completely engaged under the tooth upon visual inspection.The needle was completely engaged under the tooth.Successful activation was achieved without breaking the safety sheath and no difficulty was experienced.A review of the device history inspection records indicated that there were no production related problems.Although the cause of the reported event cannot be definitively determined based upon the available information, there is no evidence that this event was related to a device defect or malfunction.The device labeling does address the potential for such an occurrence in the warnings/cautions and the instructions-for-use with statements such as the following: (1) "position sheath approximately 45 degrees to a flat surface.Press down with a firm, quick motion until a distinct audible click is heard"; and (2) "visually confirm that the needle is fully engaged under the lock".All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow-up #1 for mfg.Report # 3003902955-2014-00023 to provide the results of the evaluation of the ten unopened samples returned to the manufacturing facility.

• Brand Name: SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Type of Device: TERUMO NEOLUS NEEDLE
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4251612
• MDR Text Key: 19373430
• Report Number: 3003902955-2014-00023
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2014,11/14/2014

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: 07/31/2018
• Device Catalogue Number: SG3-03L2525
• Device Lot Number: 130824A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2014
• Is the Reporter a Health Professional?: No
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2014
• Initial Date Manufacturer Received: 11/27/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2013
• 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