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

Model Number SYR, NPD 0.3CC 31G 100CT5/16" 8/CS

Device Problems Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

Consumer reported complaint for the trueplus single-use insulin syringes.Complaint was initially reported via e-mail and customer was contacted via telephone.Doctor is calling on behalf of facility.Doctor is using the syringes outside of the product's intended use of insulin administration; doctor stated that he is using the insulin syringes to inject botox into his patients.Doctor stated that the needles on the syringes were dull or had a "barb" at the end; doctor stated patients were informing the staff that the syringes were causing pain.Doctor stated he had attempted to return syringes to the pharmacy where purchased and they had referred him to the manufacturer.Doctor stated he has (b)(4) boxes, (b)(4) each, of the 31g syringes, lot number np21023.Doctor declined returning to pharmacy for replacement.

Manufacturer Narrative

(b)(4).Syringes were not returned for evaluation.Note 1: 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 16-mar-2022: h6: updated fda¿s type, findings and conclusions codes.H10: 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.

• 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: 13109651
• MDR Text Key: 286597419
• Report Number: 1000113657-2021-00806
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00021292005863
• UDI-Public: (01)00021292005863
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2024
• Device Model Number: SYR, NPD 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP21023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/05/2021
• Date Manufacturer Received: 02/17/2022
• 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