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

Model Number	SYR, LDR .3CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer reporting needle stick.Syringes were returned for evaluation.Evaluation is in process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure the replacement products resolved the initial concern, customer stated they are comfortable with the readings from the replacement products.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.The package was not open or damaged when received by the customer.Customer stated that she put her hand to pull out the syringes and she got stuck because there were no caps on some of the syringes.Customer did verify that not all of them are missing the covers.Customer did not have to seek any medical assistance.
Additional Manufacturer Narrative
Sections with additional information as of 25-mar-2024: h3: was the device evaluated by the manufacturer.If the device was not evaluated, select from the approved fda codes or select 'other' and enter text in h10.H6: updated fda¿s type, findings and conclusions codes.H10: syringe was returned; customer returned 1 syringe, unable to ship to the manufacturer due to needle exposed.Returned product was scrapped.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-009: use error caused or contributed to event.

• 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: 18287283
• Report Number: 1000113657-2023-00593
• Device Sequence Number: 6207461
• Product Code: FMF
• UDI-Device Identifier: 00021292005863
• UDI-Public: (01)00021292005863
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/24/2025
• Device Model Number: SYR, LDR .3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP22207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/09/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 03/25/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown