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

Model Number	NDL, PEN LDR TP 32G 4MM100CT 30/CS
Medical Device Problem Codes	Material Integrity Problem (2978); No Flow (2991)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation -customer had stated she did not have any of the pen needles left from the box she had used.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 pen needles.Customer stated she had purchased two boxes, same lot number, of the 32g trueplus pen needles, and that she had used pen needles from one of the boxes.Customer stated that the pen needles did not dispense the insulin, it would clog and the flow of insulin would stop.Customer stated that this happened with every other pen needle.Customer stated that the needles hurt upon insertion.Customer also stated that the pen needle had come off the injector and had gotten stuck in her abdomen.Customer stated the first time this happened she had removed the pen needle herself, and the second time she had asked a co-worker, who is a surgeon, to remove the pen needle from her abdomen (customer was at work at the time).At the time of the call, the customer felt well and did not report any symptoms.Customer stated the package had not been open or damaged when received.Customer is using compatible product.Customer stated she has been using the trueplus pen needle brand for about 3-4 months.Customer stated she did not have any pen needles left from the first box, and that she has not yet used any pen needles from the second box.
Additional Manufacturer Narrative
Sections with additional information as of 08-sept-2021: h10: pen needles were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations, no product was returned to thi, internal evaluation has been completed by the manufacturer, reported defect not reproduced on retention samples, added 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
• MDR Report Key: 11897641
• Report Number: 1000113657-2021-00336
• Device Sequence Number: 13806333
• Product Code: FMI
• UDI-Device Identifier: 00021292012816
• UDI-Public: (01)00021292012816
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 09/08/2021

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: 04/30/2025
• Device Model Number: NDL, PEN LDR TP 32G 4MM100CT 30/CS
• Device Catalogue Number: S5H01A32-100TC
• Device Lot Number: 0E614
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 09/08/2021
• 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: Required Intervention