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

Model Number	SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were returned for evaluation.Investigation pending note: manufacturer contacted customer in a follow-up call on 08-mar- 2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated initial issue has been resolved.
Event or Problem Description
Consumer reported complaint for syringes stating that the needle on the 31g syringes bend when aspirating insulin.Customer has been using the product for about two months.Customer stated the box had not been open or damaged when received.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.The syringe lot manufacturer¿s expiration date is 06/30/2022 and open vial date is two months ago.
Additional Manufacturer Narrative
Sections with additional information as of 22-april-2021: h2: device evaluation.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: syringes were returned for evaluation.Reported defect not reproduced.No defect found.Most likely underlying root cause: mlc-061 improper use/mishandle by end user.

• 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: 11574107
• Report Number: 1000113657-2021-00204
• Device Sequence Number: 19706992
• Product Code: FMF
• UDI-Device Identifier: 00041260385117
• UDI-Public: (01)00041260385117
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/22/2021

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: 06/30/2022
• Device Model Number: SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Distributor Facility Aware Date: 02/25/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1