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

Model Number	SYR, GNP .5CC 29G 100CT1/2" 8/CS
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer.No abnormalities were observed on returned syringes and retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note 1: manufacturer contacted customer in a follow-up call on 17-oct-2022 - customer was advised of management approval to issue refund.Customer stated she does not have a receipt for the syringes and that she was not going to obtain a receipt.Note 2: manufacturer contacted customer in a follow-up call on 18-oct-2022 - customer was advised refund is not able to be processed without a receipt.Customer was advised diabetic testing supplies could be sent as a courtesy, however, customer is using a different brand meter.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Complaint was received via e-mail from distributor on behalf of the customer.Customer stated in e-mail she had purchased three boxes of the 29g syringes (100 count, same lot number).Customer stated when she had attempted to administer her medication, it had been difficult to remove the orange needle cap from the syringe.Customer stated her husband had assisted in removing the cap, and in doing so, the needle had bent.Customer stated she had attempted twice with two more syringes, and with both an air pocket had formed, which customer had been unable to remove.Customer stated she had been able to administer her injection using another brand of syringe.Customer was able to be contacted via telephone.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer confirmed that she it had been difficult to remove the cap and that she had been unable to remove the air bubbles from the syringes.Customer was offered a refund by management; customer stated she was going to check the cost with pharmacy.

• 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: 15657810
• Report Number: 1000113657-2022-00564
• Device Sequence Number: 6387557
• Product Code: FMF
• UDI-Device Identifier: 00021292005818
• UDI-Public: (01)00021292005818
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 05/26/2023
• Device Model Number: SYR, GNP .5CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP20159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Distributor Facility Aware Date: 09/29/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/24/2022
• 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