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

Model Number SYR, NPD 0.3CC 30G 100CT5/16" 8/CS

Device Problem Defective Component (2292)

Patient Problem Pain (1994)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

Consumer reported complaint for the trueplus single-use insulin syringes; complaint was initially reported via e-mail and customer was contacted via telephone.Customer stated that the plunger on the 30g syringes were not working correctly.Customer stated that he has to push the plunger harder than usual in order to administer the insulin, and as a result, the syringe needle was causing him pain.The customer has used more than half of the syringes.Customer stated he is having the same issue with another lot of the syringes, internal report reference (b)(4).The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

Manufacturer Narrative

Internal report reference number: (b)(4).Additional report reference number: (b)(4).Syringes were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 11-apr-2024.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.No abnormalities observed with retention samples.Added most likely underlying root cause onto case.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: 18912056
• MDR Text Key: 337765928
• Report Number: 1000113657-2024-00109
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00021292005832
• UDI-Public: (01)00021292005832
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYR, NPD 0.3CC 30G 100CT5/16" 8/CS
• Device Lot Number: NP22050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/23/2024
• Date Manufacturer Received: 03/20/2024
• 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