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

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

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Syringes were not returned for evaluation - the customer had discarded the syringes.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for syringes.Complaint was received via e-mail from cardinal health on behalf of the customer.Customer stated the needles on the trueplus 31g single-use insulin syringes were blunt.The lot number of the syringes was not provided.The customer had discarded the syringes.No medical attention associated with the use of the product was reported.Manufacturer was unable to contact customer via telephone; no further information was able to be obtained.

• 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: 11901025
• MDR Text Key: 256169251
• Report Number: 1000113657-2021-00345
• Device Sequence Number: 1
• Product Code: FMF
• 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,distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/06/2021
• Date Manufacturer Received: 05/06/2021
• 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