MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD2 SAFETY SYRINGE NEEDLE

Catalog Number 102-SN3C2558S

Device Problems Bent (1059); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The user facility reported the safety was not locking correctly on the device.Follow up communication with the user facility reported the following: the safety would not stayed closed when they used the locking mechanism; when having difficulty sometimes, the needle bends and goes out the side of the sheath; and no impact to patient.

Manufacturer Narrative

The involved device was not returned for evaluation.Therefore, the investigation was based upon the evaluation of user facility information, and retention samples.Visual inspection of the collar, safety sheath and the sheath tooth found no defects that could affect activation of the safety device during use.The safety sheath confirmed to be properly attached on the assembled needle and the collar is fully seated on the hub.The random retention samples were further evaluated through sensory inspection.The safety needle was attached into a syringe.The sheath lugs were firmly attached to the collar ears.The sheath was moved to 135 degree position and pointed the needle downward.The sheath remained in the applied position.No movement on the sheath was observed.Confirmation of the dimension of the sheath tooth was performed on the retention samples.The tooth length, tooth base thickness and tooth tip thickness all met manufacturer specifications.Furthermore, sheath activation and sheath deactivation force were evaluated using the tensile / compression equipment meeting manufacturer specifications and had comparable results with the level test data.This shows that the safety needles can be activated with minimum force.Also, when activated, it cannot be easily detached from the sheath tooth.Molded parts undergone visual and dimensional inspection during molding process.Related testing such as sheath tooth dimension was conducted during incoming inspection prior supply to assembly area to verify quality of molded parts.The tooth holds the cannula when activated.Sheath tooth dimension were also validated to meet design requirements.During manual assembly, we have in-process inspection for visual, sensory test and functional test to assure quality performance of assembled needle.Moreover, from the monitoring conducted, records showed passed results.A simulation test was conducted: all samples were manually activated as per instructions for use (ifu).The needle was completely engaged under the tooth.Successful activation was achieved.The exact failure was not able to be reproduced.A review of the device history records confirmed that there were no product related problems.Production in-process inspection monitoring and qc outgoing inspection showed no related defect which could lead to the complaint.Thus, the lots were shipped in good quality.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the retention samples was the normal product with no inherent deficiency which would relate to the reported complaint.Proper instruction for usage of the sg2 needle was fully addressed in the instruction for use (ifu).Therefore, we recommend: (1) activating the safety sheath with a firm and quick motion on a flat surface and sheath must be positioned approximately 45 degrees.(2) also please be reminded to visually confirm that the needle is fully engaged under the lock and keep the finger or thumb behind the tab at all times to prevent needle stick.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

• Brand Name: SURGUARD2 SAFETY SYRINGE NEEDLE
• Type of Device: SAFETY SYRINGE
• 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: 4582346
• MDR Text Key: 5337326
• Report Number: 3003902955-2015-00001
• 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: Other
• Type of Report: Initial
• Report Date: 02/19/2015,03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 102-SN3C2558S
• Device Lot Number: 140726A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/19/2015
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2014
• 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