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

Model Number SYR, KGR 0.5CC 31G 100CT5/16" 8/CS

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for inaccurate dispense/ no aspiration of the 31g trueplus insulin syringes.Sister reported complaint via e-mail on behalf of the customer and was contacted via telephone.Customer has been using the syringes for one week.The package had not been open or damaged when received by the customer.The customer is concerned the syringes are unable to administer their insulin, stating that when the insulin was aspirated it would come right back out of the syringe.Customer had opened another box and had to use 5 syringes before one worked as intended; it was not disclosed if the second box had been the same lot number of syringes.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).Syringes were not returned for evaluation - customer returned the incorrect lot number of syringes.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 27-may-2022: h6: updated fda¿s type, findings and conclusions codes.H10: syringes were not returned for evaluation - customer returned the incorrect lot number of syringes.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using syringes from the same lot.No abnormalities were observed on retain samples.Most likely underlying root cause: mlc-009: use 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: 13633877
• MDR Text Key: 289096035
• Report Number: 1000113657-2022-00108
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00041260385117
• UDI-Public: (01)00041260385117
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYR, KGR 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP21141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/02/2022
• Date Manufacturer Received: 05/03/2022
• 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