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

Model Number	SYR, GNP 1.0CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus 31g syringes.Husband is calling on behalf of the customer.Husband stated when the customer attempted to inject her insulin the needles on the syringes were bent.This is not the first time the customer is using the product out of this package; customer has been using the product for three weeks.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 (b)(6) 2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated the replacement product (obtained from pharmacy) had resolved the initial concern.
Additional Manufacturer Narrative
Corrected sections as of 13-may-2022: h6: added retention code to type of investigation section.
Additional Manufacturer Narrative
Sections with additional information as of 13-may-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.Returned product was forwarded to supplier quality to contact the manufacturer.Manufacturer's investigation has been completed and root cause selected.No abnormalities observed on returned product, retain samples, and review batch record.All the test results meets the requirements.Root cause: rc-077: user 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: 13576675
• Report Number: 1000113657-2022-00093
• Device Sequence Number: 4973870
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Followup
• Report Date (Section B): 05/13/2022

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: 11/15/2023
• Device Model Number: SYR, GNP 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP20319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/26/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 04/18/2022; 04/18/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/13/2022; 05/14/2022
• 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