MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD 2 SAFETY NEEDLE; SAFETY SYRINGE

Catalog Number 102-N231S

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The involved device was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based upon the evaluation of the user facility information, and evaluation of retention samples.A visual inspection revealed no anomaly or defects that could affect activation of the safety device during use.The safety sheath was properly attached on the assembled needle and the collar was fully seated on the hub.The 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.The retention samples were subjected for functional tests such as sheath radial strength.This evaluation is to determine the twisting force required to break the sheath.All samples passed and within manufacturer specification.Furthermore, sheath activation and deactivation of retention samples confirmed to meet manufacturer specifications and having comparable results with the level test data.In-process inspection wherein the condition of the safety sheath is part of our check items.The sheath teeth are present and fully formed.Based on the sensory test, the hinge motion force and component fit is monitored.Functional test of manual sheath activation also showed passed results.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 test was conducted to reproduce the defect: retention samples were manually activated as per instructions for use (ifu), by pressing down with firm and quick motion.Audible sound (click) was heard and the needle was completely engage under the tooth.Successful activation was achieved without any breakage or damage on the sheath, as well as detachment of the sheath.The exact failure was not able to be reproduced.Lot history files showed no trouble encountered that could contribute or lead to similar defect.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.Although the exact cause cannot be determined, based on the simulation, the hinge was functioning and a successful activation was achieved.The needle was completely engaged / locked under the tooth during activation of the safety device.No difficulties were noted.The device can be easily activated by thumb activation, quick motion as indicated in the ifu.We cannot identify the cause of the defect to be related to our process or product.Since no actual samples were provided, thus our investigation is limited only to the information provided.Proper instruction for usage of the sg2 needle was fully addressed in the instruction for use (ifu) indicated on our unit box.Therefore, we recommend (1) activating the safety sheath with a firm and quick motion on a flat surface and sheath must be positioned approximately 450.(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.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).Device not returned to manufacturer.

Event Description

The user facility reported the clicker device (safety feature) was not sturdy as previous product.Follow up communication with the user facility reported the following: (1) it is smaller, thinner and flimsy when you click it closed; (2) the hinge tends to bend and the safety cover does not want to cover the needle; (3) no injuries to report; and (4) no impact to the patient.

Manufacturer Narrative

This report is being submitted as follow-up # 1 to correct the conclusion statement that was reported in the initial report.The initial reports states in the conclusion: "the device can be easily activated by thumb activation, quick motion as indicated in the ifu." the correct statement in the conclusion should be: "the device can be easily activated by pressing down with a firm and quick motion on a flat surface as indicated in the ifu.".

• Brand Name: SURGUARD 2 SAFETY 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, reg. no. 3003902955 ; RP
• Manufacturer Contact: kathleen little ; reg. no. 2243441; 2101 cottontail ln.; summerset, NJ 08873 ; 8002837866
• MDR Report Key: 5003111
• MDR Text Key: 22948436
• Report Number: 3003902955-2015-00014
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/17/2015,08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 102-N231S
• Device Lot Number: 141210B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Report to Manufacturer: 07/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• 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