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

Catalog Number SG2-2038

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

The user facility reported device broke during administering of vivitrol suspension.Follow-up communication with the user facility confirmed; patient may have received only 0.4ml of the medication because only 3ml was left in the syringe; and there was no injury as a result.

Manufacturer Narrative

The involved device was not returned for evaluation, which limits the failure investigation.The investigation was based upon assessment of user facility information and evaluation of reserve samples from the reported lot and current lot samples.No abnormalities or defects were noted on visual inspection and all samples passed functional testing.A simulation test was performed on a retention sample.The safety needle was securely attached to a 5ml syringe.Sterile water for injection was withdrawn from the vial and then injected into a simulated arm at a 90 degree angle as well as a 45 degree angle.No break on the needle and hub was noted.A review of the device history records and inspection records indicated that there were no production related problems.A review of the complaint files confirmed that this lot number has not been reported previously.Although the cause for the reported break cannot be definitively determined based upon the available information, there is no indication that the event was related to a pre-existing device defect.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

(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: 3848935
• MDR Text Key: 20860527
• Report Number: 3003902955-2014-00009
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2014,06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: SG2-2038
• Device Lot Number: 131024B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2014
• Date Manufacturer Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2013
• 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
• Treatment: ALKERMES MANUFACTRUED VIVITROL KIT