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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD3 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

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TERUMO PHILIPPINES CORPORATION SURGUARD3 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK Back to Search Results
Model Number N/A
Device Problem Use of Device Problem (1670)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/31/2017
Event Type  malfunction  
Manufacturer Narrative
The actual device was not returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, and retention samples of the involved product/lot number combination.Visual inspection revealed no defects.A review of the lot history files was conducted with no findings.Prior to shipment, qc conducts outgoing visual inspection, sensory inspection and functional testing all samples for the complaint lot passed.The user facility reported a similar event from the same product code/lot number combination.See mdr's 3003902955-2017-00042 and 3003902955-2017-00040.The investigation results verified that the retention sample was the normal product.Without the return of the actual device, the exact cause cannot be definitely determined.(b)(4).
 
Event Description
The user facility reported needle stick injury.The safety needle was used as intended but either the needle pushed through the side of the shield or the needle was just not properly secured in the safety portion causing the tip to push forward and be exposed outside the housing.It was reported that there was no impact on actual patient, who received injection as intended.Additional information was received on 11/7/2017: the hcp activating safety on sg3 post procedure, and was stuck when needle was not secured in as thought.The hcp activated against hard surface (table).Facility protocol followed for post exposure testing, which was negative, and hcp returned to work with no harm.
 
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Brand Name
SURGUARD3 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 Key7068162
MDR Text Key93869520
Report Number3003902955-2017-00041
Device Sequence Number1
Product Code MEG
UDI-Device Identifier34806017508204
UDI-Public34806017508204
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 11/29/2017
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 Expiration Date01/31/2022
Device Model NumberN/A
Device Catalogue NumberSG3-2525
Device Lot Number170204D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/02/2017
Initial Date FDA Received11/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age47 YR
Patient Weight71
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