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

Model Number	SYR, HMT 1.0CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer: reported defect not reproduced on retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call to ensure the initial concern is resolved - unable to establish contact with customer at this time.Note: manufacturer contacted caregiver in a follow-up call on 08-feb-2022 to ensure the customers new replacement products are not inaccurate dispense/ no aspiration as previously stated by the customer.Caregiver stated she was driving and that pharmacy gave them a replacement that will expired on april 2022.Customer wont be able to use the syringes left on the box by then.She wants us to contact the pharmacy because they tried to tell the pharmacist but caregiver said that they knew but they were "rude" and they won't give them a replacement with a long expiration date.She doesn't have any information with her but she asked me to call her back tomorrow to get all the details about the complaint.Note: manufacturer made several attempts to contact customer to ensure the customer¿s initial concern was resolved- unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Distributor and pharmacy reported complaint on behalf of the customer.No symptoms or medical attention associated with the use of the product was reported.Per pharmacist the "syringes won¿t hold medication.¿ manufacturer contacted pharmacist.Pharmacist didn¿t have all the details of the issue and did not know how many syringes are alleged as defective.Pharmacist provided phone number for the customer's caregiver.Manufacturer was unable to contact caregiver via telephone.No further information was able to be obtained.

• 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: 13546179
• Report Number: 1000113657-2022-00083
• Device Sequence Number: 17573138
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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: 04/21/2022
• Device Model Number: SYR, HMT 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19098
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/16/2022
• 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