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

Catalog Number SG3-1838

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 broke.Follow up communication with the user facility reported the following: (1) the sheath disconnected from the hinge; and (2) no impact to the patient.

Manufacturer Narrative

Results: is based upon the evaluation of the user facility information & the returned photo; based upon the evaluation of the retention and current lot sample.Conclusions - based upon evaluation of the user facility information & the returned photo; based upon evaluation of the retention and current lot samples.The involved device was not returned to the manufacturing facility but a photo was provided by the user facility.Therefore, the failure investigation was limited to assessment of information provided by the user facility, evaluation of retentions samples, current lot samples and a picture provided by the user facility.Visual inspection of the photo confirmed the safety sheath was detached from the needle and syringe.A visual inspection of the retention and current lot samples revealed no anomaly or defects.The retention samples were further evaluated through sensory inspection.The safety sheath was properly attached on the assembled needle and the collar is fully seated on the hub.The sheath lugs were firmly attached to the collar ears.This indicates that the sheath is in normal alignment.The sheath was moved to 110 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 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 met manufacturer specification, with comparable results with the level test data.Retention samples undergone sheath activation and deactivation tests.All samples passed manufacturer specification and have comparable results with the level test data.A simulation test was conducted on the retention samples.Aspiration of sterile water for injection was performed.Then, manually activate as per instructions for use (ifu), by thumb activation.Successful activation was achieved with no anomaly.The exact failure was not able to be reproduced.Lot history file revealed no product related problems for this lot.Production in-process inspection monitoring and qc outgoing inspection confirmed no product related problems.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 retentions samples was the normal product with no inherent deficiency which would relate to the reported complaint.Proper instruction for usage of the sg3 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: SURGUARD3 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: 4706283
• MDR Text Key: 17626165
• Report Number: 3003902955-2015-00006
• 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
• Report Date: 03/23/2015,04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: SG3-1838
• Device Lot Number: 130207C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Report to Manufacturer: 03/23/2015
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2013
• 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