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

Model Number	SYR, GNP 1.0CC 31G 100CT 5/16 8/CS
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for the 31g trueplus syringes.Customer stated that when she attempted to administer her insulin it would leak from the syringe.Customer stated that the insulin would also sometimes come out of her arm.Customer stated this was the first time she was using the product out of the package.The package had not been open or damaged when received by the customer.Customer is using compatible product and the pen needle was properly aligned.The customer feels well and did not report any symptoms.Customer did not claim she was injured using the syringes and no medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 04-oct-2021: h10: syringes were not returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using syringes from the same lot.No abnormalities were observed on retain samples and review batch record.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: 12408551
• Report Number: 1000113657-2021-00528
• Device Sequence Number: 12102447
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• 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): 10/04/2021

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: 12/03/2023
• Device Model Number: SYR, GNP 1.0CC 31G 100CT 5/16 8/CS
• Device Lot Number: NP20355
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/10/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1