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

Catalog Number SG2+2525

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/29/2015

Event Type  Injury  

Event Description

The user facility reported that a needle stick incurred.Follow up communication with the user facility reported the following: after administering the product, the needle broke off the syringe while trying to place the safety cover on the needle; the needle slightly stuck the office representative.

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 the retention samples.A visual inspection revealed no anomaly or defects.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.Dimensions of the sheath tooth was performed on the retention samples.The tooth length, tooth base thickness and tooth tip thickness met manufacturer specifications.Furthermore, sheath activation and deactivation tests confirmed to meet manufacturer specifications and having comparable results with the level test data.The molded parts undergone visual and dimensional inspection during molding process.Related testing was conducted during incoming inspection prior supply to assembly area to verify quality of molded parts.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.The retention samples were manually activated as per instructions for use (ifu).Successful activation was achieved without any abnormalities.The audible sound (click) was heard and the needle was completely engaged under the tooth upon visual confirmation.The exact failure was not able to be reproduced.Lot history files revealed no trouble encountered that could contribute or lead to similar defect.Production and qc outgoing inspection revealed no related defects which could lead to this complaint.Thus, the lot was 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 retentions samples are 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) indicated on the unit box.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 activating the safety sheath with a firm and quick motion on a flat surface and sheath must be positioned approximately 450.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).Device not returned to manufacturer.

• 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 ; RP
• Manufacturer Contact: kathleen little ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4932369
• MDR Text Key: 21120407
• Report Number: 3003902955-2015-00012
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 06/29/2015,07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SG2+2525
• Device Lot Number: 130715B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/29/2015
• Device Age: 2 YR
• Date Report to Manufacturer: 06/29/2015
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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
• Patient Outcome(s): Other