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

Model Number	SYR, KGR 1.0CC 29G 100CT1/2" 8/CS
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were returned - product evaluation in-process.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using syringes from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure that the initial concern was resolved - able to establish contact with customer who stated the initial issue has been resolved.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes; complaint was initially reported via e-mail and customer had been contacted by telephone.Customer reported that 6-8 of the 29g syringes had been missing the plunger cap and that one had been missing the needle tip cover.The package had not been open or damaged when received by the customer.Customer has been using the product out of this package for about one month.The customer feels well and did not report any symptoms.The customer is not claiming to be injured using the syringes and no medical intervention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 22-mar-2023: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: syringes were returned for evaluation.Returned product was forwarded to supplier quality and internal evaluation was performed by the manufacturer.No abnormalities observed on returned products.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.

• Brand Name: SYRINGES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 16386526
• Report Number: 1000113657-2023-00082
• Device Sequence Number: 14879436
• Product Code: FMF
• UDI-Device Identifier: 00041260385063
• UDI-Public: (01)00041260385063
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 03/22/2023

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: 12/14/2024
• Device Model Number: SYR, KGR 1.0CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP21335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown