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

Model Number	SYR, NPD 1.0CC 30G 100CT5/16" 8/CS
Medical Device Problem Codes	Crack (1135); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to customer experiencing pain when using syringes.Syringes were not returned for evaluation - customer had discarded product.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.
Event or Problem Description
Consumer reported complaint for the trueplus syringes.Cardinal health reported complaint on behalf of the customer.The customer reported that the syringes were cracked, the 30g needles were bent and that pain had been experienced upon insertion.No medical attention associated with the use of the product was reported.Technician had attempted follow-up with customer had was unable to contact via telephone.
Additional Manufacturer Narrative
Sections with additional information as of 08-jul-2021: 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 using syringes from the same lot.No abnormalities were observed on retain products.Most likely underlying root cause: (b)(6): damaged during transit.

• Brand Name: SYRINGES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11793995
• Report Number: 1000113657-2021-00304
• Device Sequence Number: 3868927
• Product Code: FMF
• UDI-Device Identifier: 00021292005856
• UDI-Public: (01)00021292005856
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/24/2023
• Device Model Number: SYR, NPD 1.0CC 30G 100CT5/16" 8/CS
• Device Lot Number: NP20104
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/12/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other