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

Model Number SYR, NPD 1.0CC 29G 100CT1/2" 8/CS

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 09/20/2021

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

Consumer reported complaint for syringes.Wife is calling on behalf of the customer.Customer had purchased 100 count of the 29g syringes and stated some appear to have an extra piece of metal sticking out of them.Customer stated they have "barbs" that catch his skin when he uses them, and that they hurt and bruise his skin.No medical intervention related to the use of the syringes was reported.At the time of the call the customer felt well and did not report any symptoms.The package had not been open or damaged when received by the customer.

Manufacturer Narrative

Sections with additional information as of 04-jan-2022 h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: syringes were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations, no product was returned to thi, internal evaluation has been completed by the manufacturer, reported defect not reproduced on retention samples.Most likely underlying root cause: mlc-009: user error caused or contributed to event.

• 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: 12639796
• MDR Text Key: 276658563
• Report Number: 1000113657-2021-00654
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00021292005825
• UDI-Public: (01)00021292005825
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/10/2024
• Device Model Number: SYR, NPD 1.0CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP21026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/20/2021
• Date Manufacturer Received: 12/07/2021
• 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