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

Model Number	PNDL, 3BV TVH TP 32G 4MM100CT 30/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation and pending completion of evaluation.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - able to establish contact with customer and stated condition improved.Customer stated she had 6 pen needles with the same issue.She discarded four (4) pen needles and only has two (2) to return for investigation.The customer is using humalog pen and 32 gauge.Customer was able to administer insulin on (b)(6) 2020 with one of the trueplus pen needles that was not bend.Customer did not seek medical attention and is no longer experiencing symptoms.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated she is using competitor's pen needles.
Event or Problem Description
Consumer reported complaint for bent and dull pen needles.The customer did report symptoms of bleeding- creating lumps on skin.Customer is using compatible insulin pen, humalog pen.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.The pen needle lot manufacturer¿s expiration date is 09/01/2023 and open vial date is undisclosed.
Additional Manufacturer Narrative
Sections with additional information as of 21-may-2020: h10: pen needles were returned for and evaluated by manufacturer.Manufacturer stated that based on the archival sample the defect is not confirmed.In the sample from the customer, 1 piece of bent needle was observed.Most likely underlying root cause: rc-076: mishandled by the end user.

• 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
• MDR Report Key: 9933053
• Report Number: 1000113657-2020-00205
• Device Sequence Number: 2851298
• Product Code: FMI
• UDI-Device Identifier: 00021292009076
• UDI-Public: (01)00021292009076
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• 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): 05/21/2020

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: 09/01/2023
• Device Model Number: PNDL, 3BV TVH TP 32G 4MM100CT 30/CS
• Device Catalogue Number: S5H01A32-100
• Device Lot Number: Y58ZB1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Distributor Facility Aware Date: 03/09/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1