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

Model Number SYR, NPD 1.0CC 31G 100CT5/16" 8/CS

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were not returned for evaluation.Most likely underlying root cause: mlc-61: improper use / mishandled by end user.Note: manufacturer is unable to contact customer in a follow-up call to ensure the replacement products resolved the initial concern due to customer declining thi to store any personal information in system.Note: customer declined to send any syringes back for investigation stating that she only wants the complaint noted.

Event Description

Consumer reported complaint for bending of syringe upon drawing of insulin.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.Customer states that when she removes the cap from the syringe to expose the needle to use the syringe and she attempts to draw the insulin; the needle will not pierce the top portion of the insulin bottle and bends.

• 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: 10007697
• MDR Text Key: 218021289
• Report Number: 1000113657-2020-00269
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/18/2021
• Device Model Number: SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP18322
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/02/2020
• Date Manufacturer Received: 04/02/2020
• 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