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

Model Number	SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10228224
• Report Number: 1000113657-2020-00455
• Device Sequence Number: 3142979
• Product Code: FMF
• UDI-Device Identifier: 00021292005870
• UDI-Public: (01)00021292005870
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other