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

Catalog Number 6SG2-1938

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

The user facility reported that the safety cover separated from the needle on activation.Follow up communication with the user facility confirmed that there was no patient injury.

Manufacturer Narrative

Results: based upon evaluation of user facility information & the returned sample, 213 is based upon evaluation of retention samples from representative lots conclusions: based upon evaluation of user facility information & the returned sample, 71 is based upon evaluation of retention samples from representative lots the involved device was returned to the manufacturing facility for evaluated.The actual sample was separated into two parts.The collar with safety sheath was disconnected from the needle assembly.Visual inspection was noted to have deep scratches and damages found in hub steps and ribs.The hub showed signs that it had contact with a sharp object.There were deep scratches and damages under 21 x magnifications.It has a line scratch and showing a signs that undergone extreme force.There are scratches observed in the hub and collar's steps, hub ribs and hub flange.The damages on the inner collar steps shows indications that it might have undergone screwing or twisting under 21 x magnifications.Samples from representative lots were also visually inspected.The collar, safety sheath and the sheath tooth were free from molding related defects and damages or deformations that could affect activation of the safety device during use.The safety sheath is properly attached on the assembled needle and the collar is fully seated on the hub.These samples were also subjected to collar removal test.This is an evaluation to verify the force required to detach the collar from the needle hub.All the samples conforms to the specification, an average of 33 n is needed to remove the collar from the needle hub.This shows that the product undergone proper collar assembly and cannot be easily detached.Lot history file revealed no non-conformance related to damage on collar and hub.A review of the complaint files confirmed that this type of issue has not been previously reported.Although the exact cause cannot be determined based on the available information, there is no evidence that this event was related to a device defect or malfunction.The appearance of the involved sample showed that it had undergone contact with a sharp object and excessive force that could have resulted in the detached collar.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

• Brand Name: SURGUARD2 SAFETY NEEDLE
• Type of Device: TERUMO NEOLUS NEEDLE
• 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: 4262340
• MDR Text Key: 5030624
• Report Number: 3003902955-2014-00026
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/23/2014,11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6SG2-1938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2014
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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