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

Model Number	SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2020
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-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 - unable to establish contact with customer at this time.Customer refused to give personal information.No product notification letter sent since no customer address on file.
Event or Problem Description
Consumer reported complaint for syringe bending when inserting syringe into insulin bottle.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 11/18/2021 and open date is approximately one month ago.

• 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: 10051554
• Report Number: 1000113657-2020-00298
• Device Sequence Number: 2706902
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• 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): 05/13/2020

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: 11/18/2021
• Device Model Number: SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP18322
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1