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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVIDIA HEALTH INC SYRINGES PISTON SYRINGE

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TRIVIDIA HEALTH INC SYRINGES PISTON SYRINGE Back to Search Results
Model Number SYR, HMT 1.0CC 31G 100CT5/16" 8/CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
Internal report reference number: (b)(4). Syringes were not returned for evaluation. Most likely underlying root cause: mlc-61: improper use / mishandled by end user. Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time. Product notification letter sent to contact customer care.
 
Event Description
Consumer reported complaint for potential risk associated with needle stick. Husband sent emailing on behalf of the customer. Customer stated that his wife was opening a new bag of syringes. One of the syringes did not have a cap on and stuck her finger. The customer did not report symptoms. Medical attention is not reported as a result. The product storage location is undisclosed. The syringe lot manufacturer¿s expiration date is 04/16/2022 and open date is undisclosed.
 
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Brand NameSYRINGES
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
TRIVIDIA HEALTH INC
2400 nw 55th court
fort lauderdale FL 33309
Manufacturer Contact
karen devincent
2400 nw 55th court
fort lauderdale, FL 33309
MDR Report Key10106785
MDR Text Key221280871
Report Number1000113657-2020-00354
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00021292005887
UDI-Public(01)00021292005887
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/16/2022
Device Model NumberSYR, HMT 1.0CC 31G 100CT5/16" 8/CS
Device Lot NumberNP19089
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date05/04/2020
Event Location No Information
Date Manufacturer Received05/04/2020
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

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