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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 Needle Stick/Puncture (2462)
Event Date 10/14/2017
Event Type  malfunction  
Manufacturer Narrative
Ethnicity - requested but not provided.Udi - unknown due to the lot number being unknown.Lot number: unavailable.Expiration date - unknown due to the lot number being unknown.Explanted date: device was not implanted.Device manufacture date - unknown due to unknown lot number.The actual device was not returned for evaluation and the product code and lot are unknown.No evaluation could be conducted due to the device not being returned.There is no evidence that this event was related to a device defect or malfunction.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.Prior to shipment, qc conducts outgoing visual inspection and all samples for the complaint lot passed.The user facility reported similar events from the same product code/lot number combination.See mdrs 3003902955-2017-00043, 3003902955-2017-00044, 3003902955-2017-00045, and 3003902955-2017-00046.(b)(4).
 
Event Description
The user facility reported a needle stick.It was reported that no needles were noted to be bent prior to activation of safety device.Hcp affected on incident.The patient was not affected.
 
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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 Key7137446
MDR Text Key96041014
Report Number3003902955-2017-00054
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 12/21/2017
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-N231S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/21/2017
Initial Date FDA Received12/21/2017
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
Patient Age28 YR
Patient Weight57
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