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

Model Number SYRINGES

Device Problem Material Twisted/Bent (2981)

Patient Problem Skin Tears (2516)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report: (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 that the replacement products resolved the initial concern - able unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for syringe needle broken/warped.The customer did report skin ripping and bleeding.Medical attention is not reported as a result.The product storage location is undisclosed.The syringe lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report: (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 that 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 syringe needle broken/warped.The customer did report skin ripping and bleeding.Medical attention is not reported as a result.The product storage location is undisclosed.The syringe lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.

Event Description

Consumer reported complaint for syringe needle broken/warped.The customer did report skin ripping and bleeding.Medical attention is not reported as a result.The product storage location is undisclosed.The syringe lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report: (b)(4) syringes were 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 that the replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.

• 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: 8745735
• MDR Text Key: 151001880
• Report Number: 1000113657-2019-00692
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• 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: NP18088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY; SECOND THERAPY