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	Dull, Blunt (2407); Material Integrity Problem (2978)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were returned for evaluation.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on 18-oct-2021 to ensure the initial concern is resolved - able to establish contact with customer who stated replacement syringes were received from the pharmacy and that the initial concern has been resolved.
Event or Problem Description
Consumer reported complaint for the 31g syringes.Customer stated she started using the syringes a few days prior and that this is the first time she is using this brand.Customer stated that the end of the needle has "burs" and is not as smooth as it should be.Customer stated it is very hard to insert the needle into her skin and that it hurts.At the time of the call, the customer felt well and did not report any symptoms.No medical intervention associated with the use of the product was reported.Customer stated she had discarded the syringes she had used.
Additional Manufacturer Narrative
Sections with additional information as of 30-nov-2021: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: syringes were returned for evaluation.Returned product was forwarded to supplier quality to contact the manufacturer.Manufacturer's investigation has been completed.Reported defect not reproduced on the syringes and no abnormalities on retain samples, and review batch record.All the test results meets the requirements.Most likely root cause: mlc-061: improper use/mishandle by 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: 12787916
• Report Number: 1000113657-2021-00709
• Device Sequence Number: 17416948
• Product Code: FMF
• UDI-Device Identifier: 00021292005863
• UDI-Public: (01)00021292005863
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/30/2021

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: 01/03/2024
• Device Model Number: SYR, NPD 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP21023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/13/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 11/30/2021
• 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