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

Catalog Number 3SG2-2525

Device Problems Break (1069); 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 device was flimsy.Follow up communication with the user facility reported the following: (1) the safety is hard to put in place, as well as it has broken a few times; (2) the safety was difficult to use and the safety guard broke off a couple times; (3) no needle sticks occurred; and (4) no impact to patient.

Manufacturer Narrative

The involved device was not returned to the manufacturing facility for evaluation and the lot # is unknown.Therefore, the investigation was based upon the evaluation of the user facility information, and the retention samples from representative lots.A visual inspection revealed no anomaly or defects.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.The representative samples were subjected for functional tests such as sheath radial strength and sheath removal force.It is the twisting force required to break the sheath and the force required to remove the fitting of sheath from the collar's ears.All samples passed manufacturer specifications and have comparable results with the level test data.Likewise, representative samples undergone sheath activation and deactivation tests.All samples passed manufacturer specifications and have 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 result.A simulation test was conducted: all samples were manually activated as per instructions for use (ifu).Successful activation was achieved without any breakage or damage on the sheath, as well as detachment of the sheath.The needle was completely engaged under the tooth.Successful activation was achieved and the sheath remained intact.The exact failure was not able to be reproduced.Lot history files revealed no troubles or deviation encountered during molding and assembly of the lot.Production and qc out going inspection of the current production lots confirmed no product related problems.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 from representative lot 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) indicated on the unit box.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: SURGUARD2 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: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4582398
• MDR Text Key: 5479882
• Report Number: 3003902955-2015-00002
• 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 Catalogue Number: 3SG2-2525
• Device Lot Number: UKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Report to Manufacturer: 02/19/2015
• Date Manufacturer Received: 02/19/2015
• 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