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

Catalog Number UKN

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

The user facility reported that the needle became detached from syringe.Follow-up communication with the user facility confirmed; (1) during post treatment the needle became detached from the syringe and landed in the patients bed; (2) a staff member found the needle; (3) there was no needle stick; and (4) there was no patient impact.

Manufacturer Narrative

The actual device has not been returned for evaluation and 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 report is being submitted as follow-up #1 for mfg.Report # 3003902955-2014-00025 to provide sample evaluation results.The involved device was not returned for evaluation.The investigation was based upon assessment of user facility information and evaluation of representative samples.Visual inspection confirmed the collar and safety sheath tooth were free from molding related defects and damages or deformations that could affect activation of the safety device during use.The safety sheath of the representative samples are properly attached on the assembled needle and the collar is fully seated on the hub.This indicates that the sheath is in normal alignment.Simulation testing was conducted.Syringes with different sg3 needle gauge representatives were used in the simulation.The syringe was tightened to the needle by gripping the base of the needle, not the safety sheath, push and turn the syringe clockwise.Then, manually activate as per instructions for use (ifu), by finger activation, thumb activation, and surface activation.The needles were completely engaged under the tooth.Successful activation was achieved.There was no detachment of the needle from the syringe.An audible sound (click) was heard and the needle was completely engage under the tooth upon visual confirmation.Also no abnormalities were observed.A review of the device history record confirmed that there were no production related problems for this lot number.Although the cause for the reported event cannot be definitively determined based on the available information, there is no indication that the event was related to a device defect or malfunction.All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-ups.

Event Description

This report is being submitted as follow-up #1 for mfg.Report # 3003902955-2014-00025 to provide sample evaluation results.

• Brand Name: SURGUARD3 SAFETY 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: 4247514
• MDR Text Key: 5109592
• Report Number: 3003902955-2014-00025
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113422
• 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: 10/15/2014,11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UKN
• Device Lot Number: UKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2014
• Date Manufacturer Received: 10/24/2014
• 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
• Treatment: BLOOD GAS SYRINGE