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 10/02/2013

Event Type  malfunction  

Event Description

This report is being submitted in response to the medwatch report # (b)(4) which was received from the fda on (b)(4) 2014.The event description states the following: "i incurred a needlestick injury after engaging what i thought was a locking mechanism.The degarelix injection has a flap which does not lock and falls right off the needle after applied.I administered the injections to the patient's abdomen subq while in the quick inject room, i then applied the flap to the needle then disposed of the needle in chemo disposal bag for transport to the soiled utility room.During transport, i incurred a needlestick injury through the chemo disposal bag.Degarelix injection with terumo safety hypodermic needle is a onetime loading dose used as initial treatment prior to continuous treatment with lupron." follow-up communication with the user facility confirmed the nurse incurred a needlestick and received no medical treatment.

Manufacturer Narrative

The involved device was not returned for evaluation, which limits the failure investigation.The user facility was unable to determine the specific lot number involved, but returned samples from the current pharmacy inventory ((b)(4)) were evaluated.Retention samples were subjected to inspection.No abnormalities or defects were noted on visual inspection and all samples passed functional testing.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 warnings/cautions and the instructions-for-use with statements such as the following: (1) "handle with care to avoid needlesticks"; (2) "keep hands behind the needle at all times during use and disposal"; (3) "for greatest safety, activate the sheath using a one-handed technique"; (4) "if a needle is bent or damaged, no attempt should be made to straighten needle or use the product"; (5) "position sheath approximately 45 degrees to a flat surface.Press down with a firm, quick motion until a distinct audible click is heard"; (6) "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 for appropriate tracking, trending and follow-up.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

This report is being submitted as follow-up #1 for mfg.(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: 3658317
• MDR Text Key: 20358934
• Report Number: 3003902955-2014-00004
• 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
• Report Date: 11/25/2013,10/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SG2-2525
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2013
• Distributor Facility Aware Date: 10/02/2013
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2014
• Date Manufacturer Received: 08/15/2014
• 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
• Treatment: DEGARELIX KIT BY FERRING PHARMACEUTICALS