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

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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were not returned for evaluation.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 replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.

Event Description

Consumer reported complaint for potential risk associated with needle stick.Husband sent emailing on behalf of the customer.Customer stated that his wife was opening a new bag of syringes.One of the syringes did not have a cap on and stuck her finger.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The syringe lot manufacturer¿s expiration date is 04/16/2022 and open date is undisclosed.

• 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: 10106785
• MDR Text Key: 221280871
• Report Number: 1000113657-2020-00354
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/01/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2022
• Device Model Number: SYR, HMT 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19089
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/04/2020
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 06/01/2020
• 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