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

Model Number	SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Note: manufacturer contacted pharmacy in a follow-up call on 27-dec-2022 to ensure that the initial concern was resolved - pharmacy stated they would be sending the product back; it was not disclosed if the initial issue was resolved.
Event or Problem Description
Consumer reported complaint for labeling issue with the trueplus single-use insulin syringes.Pharmacist is calling on behalf of the customer.Pharmacist stated that customer returned a box of syringes due to the incorrect syringes being in the box: pharmacist stated that the box reads 1/2" cc 31-gauge syringes, however what was in the box was the 1/2 cc 29-gauge syringes.Pharmacy stated that box was sealed and intact when they received it and when it was dispensed to the customer.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 02-feb-2023: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: syringe lot np21140 (4) were returned for evaluation - received a cut off piece carton from lot np20329 with details for kgr 0.5cc 31g and four syringes inside its original plastic bag, lot np21140 for 29g syringe.Returned product was forwarded to supplier quality and internal evaluation was performed by the manufacturer.Per manufacturer investigation report, returned sample np21140 was worked on june 18, 2021.Therefore, it cannot be mixed.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: 16113661
• Report Number: 1000113657-2023-00008
• Device Sequence Number: 20954786
• Product Code: FMF
• UDI-Device Identifier: 00041260385117
• UDI-Public: (01)00041260385117
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/01/2023
• Device Model Number: SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP20329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown