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

Model Number	SYR, KGR 0.3CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were returned for evaluation.No defect was detected.Most likely underlying root cause: improper use / mishandled by end user, note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for inaccurate dispense/aspiration of the syringes.Customer stated that the rubber part sticks on some of the syringes.Customer also stated that some of the syringes did not have a needle; customer had discarded those without the needle.The package was not opened or damaged when received by customer.The customer feels well and did not report any symptoms.Customer is not claiming they were injured using the product.No medical intervention related to the use of the product was reported.

• Brand Name: SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10088444
• Report Number: 1000113657-2020-00330
• Device Sequence Number: 11357677
• Product Code: FMF
• UDI-Device Identifier: 00041260385100
• UDI-Public: (01)00041260385100
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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 Expiration Date: 05/12/2022
• Device Model Number: SYR, KGR 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Distributor Facility Aware Date: 04/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1