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

Model Number	SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4) additional report reference number (b)(4): initial customer call.Syringes were returned - product evaluation in process.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) 2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes, stating that the plunger on the 31g syringes was out of the protective cover; customer stated that the orange cap on some of the syringes was off.The package was not open or damaged when received by the customer.Customer stated that she opened this box a week and a half ago.The customer feels well and did not report any symptoms.Customer did not claim to be injured while using the syringes and no medical attention associated with the use of the product was reported.

• Brand Name: SYRINGES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 19539125
• Report Number: 1000113657-2024-00257
• Device Sequence Number: 6216410
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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 Model Number: SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP23124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Distributor Facility Aware Date: 05/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/14/2024
• 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