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

Model Number	SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Received an open bag with one orange cap and no syringe.Unable to send to manufacture for investigation.Product scrapped.Note: manufacturer contacted customer in a follow-up call 06-sep-2023 to ensure the replacement products resolved the initial concern, able to contact customer who stated they have received the replacement product and voiced no further concerns.
Event or Problem Description
Consumer reported complaint for syringe is out of the protective cover.Customer states that the top part where she removes the plunger is missing from the syringes, a few of them in the bag the top part of the syringes is not on the syringes.Customer states that orange top is in the bag but it is on the top of syringes.The syringe is out of the protective cover.The customer feels well and did not report any symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The syringe lot manufacturer¿s expiration date is 11/27/2027and open vial date is undisclosed.
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 - received in an open bag with one orange cap and no syringe.Unable to send to manufacturer for investigation.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-028: there was not enough information to determine the mlurc.

• 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: 17721923
• Report Number: 1000113657-2023-00464
• Device Sequence Number: 7213103
• Product Code: FMF
• UDI-Device Identifier: 00021292005870
• UDI-Public: (01)00021292005870
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP22299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/11/2023
• 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
• Patient Sex: Unknown