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

Model Number	SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer reporting needle stick due to missing cap on syringe.Syringes were not returned for evaluation.Note 1: manufacturer contacted pharmacist in a follow-up call on 23-aug-2023 to ensure the replacement products resolved the initial concern - able to establish contact with pharmacist who stated they were unsure if the replacement product had been received.Note 2: manufacturer contacted pharmacist in a follow-up call on 28-aug-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated they were going to check if replacement product had been received and would contact manufacturer.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Pharmacist is calling on behalf of the customer.Customer reported that one of the 31g syringes did not have a cap on it and the customer had stuck themselves with the needle.No medical attention associated with the use of the product was reported.The package was not open or damaged when received by the customer.Customer had purchased a new box of syringes and pharmacist is calling for replacement.
Additional Manufacturer Narrative
Sections with additional information as of 19-oct-2023: h6: updated fda¿s type, findings and conclusions codes.H10: syringes were not returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using syringes from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• Brand Name: SYRINGES
• Common Device Name: 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: 17652322
• Report Number: 1000113657-2023-00448
• Device Sequence Number: 20636247
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP22302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/14/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown