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

Model Number	SYR, GNP .5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were returned for evaluation.Investigation in process note: manufacturer contacted customer in a follow-up call on 29-apr- 2021 to ensure the replacement products resolved the initial concern - able to establish contact with pharmacist who stated products resolved the customer's initial concern.
Event or Problem Description
Consumer reported complaint for the 31g syringes.Pharmacist is calling on behalf of the customer.Customer had returned two syringes to the pharmacy stating that they did not dispense the insulin.Pharmacist had also attempted to dispense the insulin into a napkin and stated that nothing had come out.The customer is using compatible product.The customer feels well and did not report any symptoms.Customer did not claim to be injured using the syringes and no medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 24-june-2021.H2 device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: two syringes arrived with unknown liquid substance inside both syringes.Pci tech did not perform any testing as there were unknown substances inside the syringes.Returned product was forwarded to supplier quality to contact the manufacturer.Manufacturer's investigation has been completed, report attached and root cause selected.Per manufacturer's report, defect found on both syringes; unable to aspirate due to improper storage of the chemical liquid in the cylinder causing syringe to be clogged.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: 11819274
• Report Number: 1000113657-2021-00313
• Device Sequence Number: 3692587
• Product Code: FMF
• UDI-Device Identifier: 00021292005870
• UDI-Public: (01)00021292005870
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 05/14/2023
• Device Model Number: SYR, GNP .5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP20161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Distributor Facility Aware Date: 04/15/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1