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

Model Number	SYR, KGR 0.5CC 29G 100CT1/2" 8/CS
Medical Device Problem Codes	Component Missing (2306); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Customer stated that from the box of 29g syringes, one needle had been missing and some of the needles were bent and unusable; customer was concerned with the product being unable to administer their insulin.Customer has been using syringes out of this package since (b)(6) 2022.The package had not been open or damaged when received by the customer.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 returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 07-mar-2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated the initial concern has been resolved and that the pharmacy has placed an order for replacement syringes as they were out of stock.
Additional Manufacturer Narrative
Sections with additional information as of 01-june-2022: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: returned product was forwarded to supplier quality to contact the manufacturer for further investigations.Manufacturer's investigation has been completed and root cause selected.Defect found on returned syringes; bent needles observed.No abnormalities observed with retain samples.However, the manufacturer issued a capa and scar 22-007 has been assigned, per thi supplier qa root cause: rc-076: mishandled by the end user.

• 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: 13860693
• Report Number: 1000113657-2022-00156
• Device Sequence Number: 14897834
• Product Code: FMF
• UDI-Device Identifier: 00041260385230
• UDI-Public: (01)00041260385230
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 06/01/2022

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: 11/01/2023
• Device Model Number: SYR, KGR 0.5CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP20327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/01/2022
• 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