MAUDE Adverse Event Report: TRIVIDIA HEALTH INC SYRINGES; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were returned - product evaluation in-process.Most likely underlying root cause still pending of investigation completion note: manufacturer contacted customer in a follow-up call on 6-jan-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who states the new syringes he received some of the caps seem to be stuck on the barrel of the syringe.Customer states it is difficult to uncap some of the syringes.
Event or Problem Description
Consumer reported complaint for syringes stating that the needle bent on 4 syringes and some of the syringes it was difficult to remove the cap and believed they had glue or clear plastic where the cap of syringe meets the syringe barrel.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result of the syringes.The product storage location is undisclosed.The syringe lot manufacturer¿s expiration date is 01/29/2023.
Additional Manufacturer Narrative
Sections with additional information as of 09-feb-2021: d10/h3/h6: products were returned for evaluation.Visually inspected returned syringes (2).Needle showed signs of being bent.Defect found and root cause selected.Root cause rc-076 added mishandled by the end user.Mechanical stress-handling.

• Brand Name: SYRINGES
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11169915
• Report Number: 1000113657-2021-00030
• Device Sequence Number: 12011246
• Product Code: NBW
• UDI-Device Identifier: 00021292005870
• UDI-Public: (01)00021292005870
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 02/09/2021

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: 01/29/2023
• Device Model Number: SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP20036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Distributor Facility Aware Date: 12/18/2020
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1