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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 07/18/2017
Event Type  malfunction  
Manufacturer Narrative
D4: udi - not required for the reported product code/lot number combination.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.Sheath activation test verified the retention samples passes specification.Manual activation was performed and all samples were successfully activated without difficulty.A review of the lot history files was conducted with no relevant findings.Prior to shipment, qc conducts outgoing visual inspection, sensory inspections, and functional testing and all samples for the complaint lot passed.The user facility reported a similar event from the same product code/lot number combination.See mdr 3003902955-2017-00030.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.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.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow up.
 
Event Description
The user facility reported needle sticks.The following information was provided by the user facility: our company has started using the terumo suirguard3 needles and the staff needs some education on the use of these needles especially our pediatrics department; they have had some needle sticks since using this product; and there were no other devices or equipment being used with the reported product.Additional information was received on august 1, 2017.The clinicians had needle sticks with sg3-2516.Both needle stick occurrences were from thumb activations and both did not fully engage/activate all the way, and in both instances the needle was sticking out of the sheath.When the clinicians grabbed the safety needle to discard it they held it up by the sheath/needle and got stuck by the needle.The patients were not affected, and there are not any health concerns for the clinicians.
 
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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 Key6812811
MDR Text Key83744492
Report Number3003902955-2017-00029
Device Sequence Number1
Product Code MEG
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 08/23/2017
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 Date05/31/2021
Device Model NumberN/A
Device Catalogue NumberSG3-2516
Device Lot Number160628D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/25/2017
Initial Date FDA Received08/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2016
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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