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

Model Number	SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for warped syringe needle.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of bruising.Medical attention is not reported as a result of warped syringe needle or symptom.The product storage location is undisclosed.During the call a test of the product was not performed by the customer.The test strip lot manufacturer¿s expiration date is 04/15/2021 and open vial date is undisclosed.
Additional Manufacturer Narrative
Syringes were returned for evaluation.No defect was detected.Most likely underlying root cause: mlc-61: improper use/mishandled by end user.Note: manufacturer contacted customer in a follow-up call to ensure the customer's products resolved the initial concern - able to establish contact with customer and stated will follow up with pharmacy to obtain new syringes.

• 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: 9162768
• Report Number: 1000113657-2019-10036
• Device Sequence Number: 2112936
• Product Code: FMF
• UDI-Device Identifier: 00041260385117
• UDI-Public: (01)00041260385117
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/30/2019

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: 04/15/2021
• Device Model Number: SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP18097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Distributor Facility Aware Date: 09/09/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1