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

Catalog Number SG2-2525

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

The user facility reported that a nurse incurred a needle stick while trying to engage the safety sheath feature.Follow-up communication with the user facility confirmed; the nurse was engaging the safety device with her thumb when it jammed; the nurse incurred a stick in the thumb.

Manufacturer Narrative

(b)(4).The investigation has yet to be completed.A follow-up report will be submitted when the investigation is complete.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

Manufacturer Narrative

(b)(4).The involved device is not available for evaluation.(b)(4) unused samples were returned by the user facility for evaluation.The returned unused samples plus retained samples from the reported lot were inspected.No abnormalities or defects were noted on visual inspection and all samples passed functional testing.A review of the device history record confirmed that there were no production related problems for this lot number.A review of the complaint files confirmed that this lot number has not been reported previously.There is no indication that the event was related to a pre-existing device defect.Although the cause for the reported event cannot be definitively determined based on the available information, the event description is most consistent with the end-user not following the proper technique per the instructions-for-use in trying to activate the safety feature.The device labeling does address the potential for such an occurrence in the instructions-for-use with statements such as the following: (1) "position the sheath approximately 45 degrees to flat surface"; (2) "press down with a firm, quick, motion until a distinct audible click is heard"; (3) "visually confirm that the needle is fully engaged under the lock"; and (7) "dispose of used needles and materials following the policies and procedures of your facility as well as federal and local regulations for sharps disposal." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending, and follow-up.

Event Description

This report is being submitted as follow-up #1 for mfg.Report 3003902955-2014-00006 to provide additional information regarding evaluation of the returned sample.

Manufacturer Narrative

(b)(4).

Event Description

(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 MD 21921 ; RP 21921
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna MD 21921 ; RP 21921
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 3826800
• MDR Text Key: 15808477
• Report Number: 3003902955-2014-00006
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2014,05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: SG2-2525
• Device Lot Number: 131202A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/22/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2014
• Date Manufacturer Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2013
• 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