MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age - requested but not provided.Ethnicity - requested but not provided.Implanted date: device was not implanted.The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based on the evaluation of user facility information and evaluation of a retention sample from the reported product code/lot number combination.Visual inspection revealed no defects.Functional testing was conducted.Sheath activation and sheath deactivation force of the retention samples were evaluated using the tensile / compression equipment and confirmed to meet manufacturer specification.This shows that the safety needles can be activated with minimum force.Also, when activated, it cannot be easily detached from the sheath tooth.Prior to shipment, qc conducts outgoing visual inspection to assure all lots pass.There is no evidence that this event was related to a device defect or malfunction.Without the return of the actual device the exact cause cannot be definitely determined.The user facility reported similar events from the same product code/lot number combination.See mdrs 3003902955-2017-00044, 3003902955-2017-00043, and 3003902955-2017-00046.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.Exemption number e2015017.
Event or Problem Description
The user facility reported that the device bends back toward the user when the safety is initiated.It was reported that the needle was not bent prior to activation of safety device.The safety needles was activated against a hard flat surface.

• Brand Name: TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• MDR Report Key: 7099098
• Report Number: 3003902955-2017-00045
• Device Sequence Number: 1272572
• Product Code: MEG
• UDI-Device Identifier: 30612479178763
• UDI-Public: 30612479178763
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 102-N231S
• Device Lot Number: 161012B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 57