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

Model Number SYR, KGR 0.5CC 31G 100CT5/16" 8/CS

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2021

Event Type  malfunction  

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 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.

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
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11574107
• MDR Text Key: 243781447
• Report Number: 1000113657-2021-00204
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00041260385117
• UDI-Public: (01)00041260385117
• Combination Product (y/n): N
• PMA/PMN Number: K993017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1