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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number:(b)(4).Syringes were not returned for evaluation.Note: manufacturer made several attempts to contact the customer to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for the trueplus syringes.Customer stated that the 29g 1 cc syringes only had five marks between each number, instead of 10.Customer expressed concern that she was not receiving the correct amount of insulin.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
Sections with additional information as of 08-april-2022.H10: medwatch report: mw5107396 was received on 03/10/2022 regarding true plus insulin syringe 29g lot number np20069: purchased insulin syringes from a company in (b)(6), used a syringe and my blood sugars went up for no apparent reason.Checked the syringe (100 u syringe with large 10 unit markings) and discovered there were only 5 units between 0 and ten units, 10 and 20 units (and so on).The syringe barrel itself looked as if it were a 50 u syringe mismarked as a 100 u syringe.Called the seller, (b)(6) who said there wasn't anything they could do and referred me to the manufacturer trividia health where i spoke to (b)(6) and emailed him pics of the syringe (b)(6).No action yet; (b)(6) is trying to connect to the (b)(4) manufacturer directly.The syringe in question: trueplus 29g 100 u insulin syringe.I fear using them again and would like clarification about the syringe's accuracy.If this syringe is off and used for a person who doesn't check their blood sugars, it could kill or hospitalize them.Fda safety report id# (b)(4).
Additional Manufacturer Narrative
Sections with additional information as of 26-may-2022: 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 were observed with retain 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: 13638681
• Report Number: 1000113657-2022-00111
• Device Sequence Number: 2134676
• Product Code: FMF
• UDI-Device Identifier: 00021292005825
• UDI-Public: (01)00021292005825
• 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,Followup,Followup
• Report Date (Section B): 05/26/2022

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 Expiration Date: 02/20/2023
• Device Model Number: SYR, NPD 1.0CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP20069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/02/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 05/03/2022; 05/03/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/08/2022; 05/26/2022
• 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