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

Model Number	SYR, NPD 1.0CC 29G 100CT1/2" 8/CS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Skin Tears (2516)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for physical harm while using the trueplus single-use insulin syringes.Cardinal health reported complaint via e-mail on behalf of the customer (reference number case (b)(4) and customer was contacted via telephone.Customer has 4 boxes of the same lot number of syringes; customer initially reported to cardinal that she had opened 2 of the boxes.Customer had stated that 20 of the syringe needles hurt to use and are so painful that due to the pain and discomfort she waits until the "the absolute last second" to administer her insulin.When contacted by telephone by the manufacturer customer stated she had only opened 1 box and that the other 3 are unopened.Customer stated that the syringes work but that they hurt and tear her skin.Customer has been using the product for 3 weeks.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
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 replacement products resolved the initial concern - unable to establish contact with customer at this time.
Additional Manufacturer Narrative
Sections with additional information as of (b)(6) 2024: h6: updated fda¿s type, findings and conclusions codes.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 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: 19096476
• Report Number: 1000113657-2024-00156
• Device Sequence Number: 20759506
• Product Code: FMF
• UDI-Device Identifier: 00021292005825
• UDI-Public: (01)00021292005825
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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 1.0CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP23053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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
• Patient Sex: Unknown