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	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Syringe were returned for evaluation and pending qc investigation.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 - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for plunger of true plus syringes not working.Customer states black stopper is separating when she attempts to pull syringe down.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 05/12/2022 and open vial date is undisclosed.
Additional Manufacturer Narrative
Sections with additional information as of 05-aug-2020: h6: updated fda's method, result, and conclusion codes h10: syringes were returned for evaluation.Defect found: black stopper separates from plunger, unable to aspirate/dispense plunger.H10: most likely underlying root cause: rc-075: supplier manufacturing defect.Corrected sections as of (b)(6) 2020: h10: most likely underlying root cause corrected from "mlc-61: improper use / mishandled by end user" to "rc-075: supplier manufacturing defect".

• 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: 10046319
• Report Number: 1000113657-2020-00286
• Device Sequence Number: 16983552
• Product Code: FMF
• UDI-Device Identifier: 00041260385100
• UDI-Public: (01)00041260385100
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 08/05/2020

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: 04/21/2020
• Distributor Facility Aware Date: 04/13/2020
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1