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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, NPD 0.3CC 31G 100CT5/16" 8/CS
Device Problems Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)
Patient Problem Pain (1994)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
Consumer reported complaint for the trueplus single-use insulin syringes. Complaint was initially reported via e-mail and customer was contacted via telephone. Doctor is calling on behalf of facility. Doctor is using the syringes outside of the product's intended use of insulin administration; doctor stated that he is using the insulin syringes to inject botox into his patients. Doctor stated that the needles on the syringes were dull or had a "barb" at the end; doctor stated patients were informing the staff that the syringes were causing pain. Doctor stated he had attempted to return syringes to the pharmacy where purchased and they had referred him to the manufacturer. Doctor stated he has (b)(4) boxes, (b)(4) each, of the 31g syringes, lot number np21023. Doctor declined returning to pharmacy for replacement.
 
Manufacturer Narrative
(b)(4). Syringes were not returned for evaluation. Note 1: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
 
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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 Key13109651
MDR Text Key286597419
Report Number1000113657-2021-00806
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYR, NPD 0.3CC 31G 100CT5/16" 8/CS
Device Lot NumberNP21023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date12/05/2021
Date Manufacturer Received02/17/2022
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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