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

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

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, 3003902955-2017-00045, and 3003902955-2017-00043.(b)(4).

Event 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
• Type of Device: SYRINGE, ANTISTICK
• 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,, reg. no. 3003902955 ; RP
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7099475
• MDR Text Key: 94268539
• Report Number: 3003902955-2017-00046
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 102-N211S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/08/2017
• 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