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

Model Number	SYR, NPD 0.3CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Customer stated that he can see metal parts tearing away from the tip of the syringes and that it hurts his abdomen when he administers his insulin.Customer stated that there was a metal piece sticking to the syringe, and that he used his finger to remove it.No further information was provided.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by the manufacturer.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event note: manufacturer made several attempts to contact customer to ensure the initial concern was resolved - unable to establish contact with customer.

• 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: 19498170
• Report Number: 1000113657-2024-00247
• Device Sequence Number: 15116477
• Product Code: FMF
• UDI-Device Identifier: 00021292005863
• UDI-Public: (01)00021292005863
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/10/2024

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 Model Number: SYR, NPD 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP23138
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/10/2024
• 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