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

Model Number SYRINGES

Device Problem Material Twisted/Bent (2981)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Consumer reported complaint for bent syringe needle causing finger stick.The customer did not report symptoms.The product storage location is undisclosed.The syringe lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.Customer stated that she was stuck with the needle while removing the protective cover, however it did not pierce the skin.Customer stated that syringes were bent when protective cover was removed.Customer does not have defective syringe package.Customer disposed of the two defective syringes and continued with the remainder syringes.Customer recently started a new batch of syringes lot np18020 exp 2021/2/11 and does not have any compliant at the moment involving bent syringes.

• Brand Name: SYRINGES
• Type of Device: BLOOD GLUCOSE SYSTEM
• 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 ; 954677-920
• MDR Report Key: 8445396
• MDR Text Key: 139731519
• Report Number: 1000113657-2019-00244
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SYRINGES
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 02/27/2019
• 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