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

Model Number	SYR, KGR 0.3CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Most likely underlying root cause: mlc-62: user had poor technique.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 that the plunger on the syringes does not work.Customer stated that when she tried to pull the plunger up, the plunger comes completely out.The package was not open or damaged when received.The customer feels well and did not report any symptoms.No adverse events were reported with the use of the product.The manufacturer's expiration date for the syringes is 04/21/2022 and package was opened in (b)(6) 2020.Customer stated that she no longer has any syringes left from this box and so is unable to send back any products for investigation.

• Brand Name: SYRINGES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10005109
• Report Number: 1000113657-2020-00264
• Device Sequence Number: 19695057
• Product Code: FMF
• UDI-Device Identifier: 00041260385100
• UDI-Public: (01)00041260385100
• Combination Product (Y/N): N
• 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): 04/28/2020

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: 04/21/2022
• Device Model Number: SYR, KGR 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19075
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1