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U.S. Department of Health and Human Services

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

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TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK Back to Search Results
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.
 
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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 Key7099475
MDR Text Key94268539
Report Number3003902955-2017-00046
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051865
Number of Events Reported1
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 NumberN/A
Device Catalogue Number102-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 Received12/08/2017
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 Number1
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