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

Model Number	PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Erythema (1840); Swelling/ Edema (4577)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Manufacturer contacted customer in a follow-up call on 31-may-2022 to ensure the customer's condition had improved - able to establish contact with customer who stated that the site where the needle is is still swollen and she will be contacting the surgeon tomorrow.Manufacturer contacted customer in a follow-up call on that the initial concern was resolved - able to establish contact with customer who stated she was in the hospital for a "couple of reasons" but did not disclose the reason for her hospitalization.Manufacturer made several attempts to contact customer to ensure the customer was no longer experiencing symptoms and to ensure the customer¿s initial concern was resolved- unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Customer stated that the pen needle had broken off and was stuck in her stomach.Customer had been unable to continue with the call as she had contacted 911.Customer was contacted the following day, (b)(6) 2022 and stated that she had been taken to the hospital the day before where they had attempted to remove the needle from her stomach but were not successful.Customer had been discharged and was advised to apply warm/hot compress to the area to see if the needle will work itself out of the skin.Customer stated that she was referred to a surgeon by the hospital but she has not yet contacted them, as she is on her way to see her doctor for a routine scheduled appointment and will show her doctor and obtain feedback.Customer stated that at the present time, the area is red and slightly swollen.
Additional Manufacturer Narrative
Sections with additional information as of 04-oct-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: 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.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: 14753761
• Report Number: 1000113657-2022-00348
• Device Sequence Number: 5582693
• Product Code: FMI
• UDI-Device Identifier: 00021292010775
• UDI-Public: (01)00021292010775
• 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): 10/04/2022

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: 06/30/2023
• Device Model Number: PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
• Device Catalogue Number: S6H01B31-100
• Device Lot Number: 8G601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/24/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 10/04/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown