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

Model Number	SYR, LDR .3CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Syringes were not returned for evaluation.Note 1: manufacturer contacted pharmacist in follow-up call on 08-dec-2021 to verify status of pictures to be sent - able to establish contact with pharmacist who stated she had received the pictures from the customer and would forward to manufacturer.Note 2: manufacturer contacted pharmacist in follow-up call on 20-dec-2021 to verify status of pictures to be sent - able to establish contact with pharmacist who stated she had attempted to forward pictures, but that the e-mail address was invalid.Manufacturer confirmed e-mail address with pharmacist; pharmacist had the correct address.Note 3: manufacturer contacted pharmacist in a follow-up call to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for the trueplus syringes.Pharmacist had reported complaint to distributor on behalf of the customer.Manufacturer was able to establish contact with pharmacist via telephone.Per pharmacist, the customer had stated that the plunger inside of the syringe is missing; pharmacist did not indicate on how many syringes this occurred.This was not the first time the customer had used the product of this package; the syringes had been dispensed to the customer on (b)(6) (50 months).The package had not been open or damaged when received by the customer.No symptoms and no medical attention associated with the use of the product were reported.Pharmacist stated that she will contact the customer to request they return the syringes, and a return envelope was sent to pharmacist.Pharmacist also advised that pictures of the product and the box that syringes were in were available; pharmacist was provided e-mail address to forward pictures.
Additional Manufacturer Narrative
Sections with additional information as of: 16-march-2022.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.Syringe was returned for evaluation.Visually inspected returned pen needle (1) and observed pen needle is missing plunger inside the syringe.Defect found.Product evaluation has been completed.Returned product was forwarded to supplier quality to contact the manufacturer.Manufacturer's investigation has been completed, and root cause selected.Most likely underlying root cause: rc-075 supplier manufacturing defect.

• 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: 13096293
• Report Number: 1000113657-2021-00801
• Device Sequence Number: 11844077
• Product Code: FMF
• UDI-Device Identifier: 00021292005863
• UDI-Public: (01)00021292005863
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 01/03/2024
• Device Model Number: SYR, LDR .3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP21002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 03/17/2022
• 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