MAUDE Adverse Event Report: TRIVIDIA HEALTH INC PEN NEEDLES FG; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	PNDL, 5BV TVH TP 32G 4MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Consumer reported complaint of inaccurate aspiration for the 32g pen needles.Customer stated the pharmacy had dispensed 50 pen needles in a brown rx bag.Customer has been using the product since (b)(6) 2022.The customer is using compatible product and the pen needle is properly aligned.Customer stated that she has some bruising at the injection site in her abdominal area.No medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 13-jun-2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated the initial concern has been resolved and she is comfortable with the product.No medical intervention since the last call was reported.
Additional Manufacturer Narrative
Sections with additional information as of 14-oct-2022: h3: was the device evaluated by the manufacturer.If the device was not evaluated, select from the approved fda codes or select 'other' and enter text in h10.H6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned - product was received out of the protective cover and unable to be shipped to manufacturer for evaluation (scrapped).Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using pen needles from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• Brand Name: PEN NEEDLES FG
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 14843420
• Report Number: 1000113657-2022-00364
• Device Sequence Number: 16739733
• Product Code: FMI
• UDI-Device Identifier: 00021292010805
• UDI-Public: (01)00021292010805
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 12/31/2024
• Device Model Number: PNDL, 5BV TVH TP 32G 4MM100CT 30/CS
• Device Catalogue Number: S6H01A32-100
• Device Lot Number: 0A603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 10/14/2022
• 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