MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. SYRINGES; BLOOD GLUCOSE SYSTEM

Model Number SYRINGES

Device Problem Material Separation (1562)

Patient Problem Bruise/Contusion (1754)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-61 -improper use / mishandled by end user.Note: manufacturer contacted customer on (b)(6) 2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the product was replaced by the pharmacy and they have not had any medical intervention or symptoms since the last call.Customer gave the syringes in question to the pharmacy.

Event Description

Consumer reported complaint for needle separate while using syringe.Customer is not claiming injury but states that she had a bruise.States she used four syringes and they all gave her the same issue.Customer states the needle came off the syringe after administering the insulin and while pulling away from the injection site.The plunger was fine and that the syringe was not bent or broken.Customer states the needle came off the syringe after administering the insulin and confirmed that the insulin did not leak out of the syringe.Customer was able to administer the insulin accordingly.Customer states there were no leaks from the syringe and therefore there was no lapse in the administration of her insulin.Customer did not have to seek medical attention.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report #: (b)(4).Product returned and investigated with no defect found.Most likely underlying root cause: mlc-61 -improper use / mishandled by end user.Note: manufacturer contacted customer on 2/13/2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the product i was replaced by the pharmacy and they have not had any medical intervention or symptoms since the last call.Customer gave the syringes in question to the pharmacy.

Event Description

Consumer reported complaint for needle separate while using syringe.Customer is not claiming injury but states that she had a bruise.States she used four syringes and they all gave her the same issue.Customer states the needle came off the syringe after administering the insulin and while pulling away from the injection site.The plunger was fine and that the syringe was not bent or broken.Customer states the needle came off the syringe after administering the insulin and confirmed that the insulin did not leak out of the syringe.Customer was able to administer the insulin accordingly.Customer states there were no leaks from the syringe and therefore there was no lapse in the administration of her insulin.Customer did not have to seek medical attention.

• Brand Name: SYRINGES
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8405450
• MDR Text Key: 141762407
• Report Number: 1000113657-2019-00200
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K993017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYRINGES
• Device Lot Number: NP18185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY