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

Model Number SYR, NPD 1.0CC 31G 100CT5/16" 8/CS

Device Problem Product Quality Problem (1506)

Patient Problem Pain (1994)

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations, no product was returned to thi, internal evaluation has been completed by the manufacturer, no abnormalities observed with retention samples most likely underlying root cause: mlc-009: use error caused or contributed to event manufacturer unable to perform follow-up call to customer to ensure the initial concern is resolved - customer had declined to provide contact telephone number at time of initial call.

Event Description

Consumer reported complaint for the trueplus single-use insulin syringes.Customer stated that when he attempts in inject the insulin, the needle is "barbed", and it is painful upon insertion into the skin and when pulling the syringe out after giving himself his dosage.Customer stated that he has been using the product for more than one month.Customer stated that he has no syringes left and that he used the last one this morning.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• Brand Name: SYRINGES
• Type of Device: 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: 15650782
• MDR Text Key: 306930291
• Report Number: 1000113657-2022-00559
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP21308
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/26/2022
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1