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

Model Number	SYR, KGR 1.0CC 29G 100CT1/2" 8/CS
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 21-nov-2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated she had attempted to return syringes to pharmacy.Customer stated the pharmacy tried three of the syringes and that they did not pierce the skin.Customer did not have pharmacy receipt; refund requested.Note 2: manufacturer contacted customer in several follow-up calls 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 single-use insulin syringes.Fiancé is calling on behalf of the customer.Customer stated that the syringes are not sharp and they do not puncture the skin.Customer also stated that the needle is not straight.The package had not been open or damaged when received ty the customer.This was the first time the customer has used the product out of this package.Customer had attempted to return syringes to pharmacy and was told to contact manufacturer for refund.The customer feels well and did not report any symptoms.The customer did not claim to be injured using the syringes and no medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 11-jan-2023: 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: 15968530
• Report Number: 1000113657-2022-00644
• Device Sequence Number: 14687013
• Product Code: FMF
• UDI-Device Identifier: 00041260385063
• UDI-Public: (01)00041260385063
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K993017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 12/14/2024
• Device Model Number: SYR, KGR 1.0CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP21335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/18/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/11/2023
• 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