MAUDE Adverse Event Report: TRIVIDIA HEALTH INC SYRINGES; PISTON SYRINGE

Model Number	SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Customer stated he had purchased a sealed box of the syringes and had found a used syringe inside the box.Customer stated the syringe had been loose at the bottom of the box.Customer also stated there had been no needle on the syringe.Customer stated he thought it might have blood inside.At the time of the call the customer felt well and did not report any symptoms.Customer did not claim to be injured while using the syringes and no medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by the manufacturer.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc note: manufacturer contacted customer in a follow-up call on 13-aug-2024 to ensure the customer¿s initial concern was resolved- the customer is comfortable with the replacement products.

• Brand Name: SYRINGES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 20050582
• Report Number: 1000113657-2024-00355
• Device Sequence Number: 15464762
• Product Code: FMF
• UDI-Device Identifier: 00041260385117
• UDI-Public: (01)00041260385117(17)281105(10)NP23151
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K993017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP23151
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/02/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown