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

Model Number SYR, NPD 0.5CC 31G 100CT5/16" 8/CS

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/03/2020

Event Type  Injury  

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

Per customer e-mail: hello, i purchased a sealed unopened box of your insulin syringes from a third party distributor recently.See all attached photos- i was stabbed reaching into a sealed package by a syringe with the orange cover off inside the closed bag.First off that is not a sterile syringe, secondly this is the third syringe out of the box of 100 that was uncapped in a sealed package.I expect something done about this immediately, otherwise i m calling the fda on your company.I am furious as a diabetic for 50 years this has never happened before.(b)(6).Customer care e-mail to customer: thank you for contacting our customer care department.We would like to apologize for any inconvenience you may be experiencing while using our true brand of products.Your health and safety are our number one priority so please allow one of our trained staff of certified technicians to assist you.In order for us to properly assist you with your blood glucose monitoring device, please provide your phone number and a representative will contact you to further assist you.Customer responded via e-mail: i look forward to that but it can be difficult getting hold of me.Ask them to leave a message (b)(6) i have photos of the package with the uncovered syringe and the box with lot code numbers.Dave attempted to contact customer at number provided; unable to make contact with customer via telephone.

• 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: 10228224
• MDR Text Key: 200601734
• Report Number: 1000113657-2020-00455
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00021292005870
• UDI-Public: (01)00021292005870
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19169
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/09/2020
• Date Manufacturer Received: 06/03/2020
• 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
• Patient Outcome(s): Other