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

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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were not returned for evaluation.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

Pharmacist reported complaint for needle stick/physical harm.Pharmacist stated that when he opened a package of the syringes, one of the needles had been sticking out, and stuck his finger.No further information was able to be obtained.

• Brand Name: SYRINGE
• 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: 10980340
• MDR Text Key: 220979088
• Report Number: 1000113657-2020-00884
• 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
• Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/13/2020
• Date Manufacturer Received: 11/13/2020
• 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