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

Model Number	SYR, NPD 0.3CC 31G 100CT5/16" 8/CS
Medical Device Problem Codes	Product Quality Problem (1506); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Additional report reference numbers: (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.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes; complaint was initially reported via e-mail and customer was contacted by phone.Customer reported complaint for 3 boxes of syringes: additional internal report reference numbers (b)(4).Customer stated that the unit measures printed on the syringes are "blurry" and appear to be double printed.Customer expressed concern that if the unit marking are not accurate or hard to read the insulin could be drawn incorrectly.Customer also reported they the syringe needles are not sharp and she is having a difficult time administering her medication.Customer did not have any of the syringes stating she had disposed of them.At the time of the call the customer felt well and did not report any symptoms.Customer did not claim to be injured while using the syringes and no medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 08-aug-2024: h10: 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 onto case: 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: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 19917606
• Report Number: 1000113657-2024-00325
• Device Sequence Number: 17953212
• Product Code: FMF
• UDI-Device Identifier: 00021292005863
• UDI-Public: (01)00021292005863(17)280910(10)NP23131
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/28/2024

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 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP23131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/12/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/28/2024
• 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