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

Catalog Number SG3-2713

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

The user facility reported that the safety device broke away from the hub of the needle.Follow-up communication with the user facility confirmed; (1) after drawing up meds using 1cc slip syringe, it was removed and replace with an sg3 to give injection; (2) after injection the needle including the hub disconnected from syringe and remained in patients arm; (3) they tried to activate the safety device with their thumb; (4) it broke away from the hub of the needle at the sheath hinge; and (5) there was no patient injury or impact.

Manufacturer Narrative

The actual device has not been returned for evaluation and 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).Device not returned.

Manufacturer Narrative

The involved device was not returned for evaluation but 12 unused samples were returned to the manufacturing facility for evaluation.Visually inspection of the 12 samples along with retention samples did not reveal any defects or abnormalities.Function testing confirmed that performance specifications were met.A review of the device history record indicated that there were no production related problems.Although the cause of the reported event cannot be definitively determined based upon the available information, there is no evidence that this event was related to a device defect or malfunction.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow-up #1 for mfg.Report 3003902955-2014-00018 to provide additional information.

• Brand Name: SURGUARD3 SAFETY HYPODERMIC 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: 4135616
• MDR Text Key: 4792523
• Report Number: 3003902955-2014-00018
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2014,10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: SG3-2713
• Device Lot Number: 130730C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/05/2014
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2014
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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