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

Model Number	PNDL, 3BV TVH TP 31G 6MMTC 100CT 30/CS PURPLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor.Pen needle was returned for evaluation.Investigation in process.Note: manufacturer contacted customer in a follow-up call on 19-apr-2021 to ensure that the initial concern was resolved - able to establish contact with customer who stated he had gone to his doctor on (b)(6) 2021 due to the pen needle being stuck in his shoulder.The doctor had informed him everything was fine and no medical treatment was provided.
Event or Problem Description
Consumer reported complaint for the pen needles.Customer pen is novolog pen.Daughter is calling on behalf of the customer.At the time of the call the customer felt well and did not report any symptoms.Customer stated that while administering his insulin on (b)(6) 2021, the pen needle had broke and had become stuck in his shoulder.Daughter stated she had manually removed the needle from the customer's shoulder and there was no swelling or bleeding after.Customer had contacted his doctor and has an appointment on (b)(6) 2021 to ensure everything is fine.Customer stated that his other pen needles are working fine.Customer is using compatible product and the pen needle was properly aligned.
Additional Manufacturer Narrative
Sections with additional information as of (b)(6) 2021: h3: was the device evaluated by the manufacturer? yes h6: updated fda's type of investigation, investigation findings, and investigation conclusions h10: customer returned one unused pen needle and one used pen needle.Visually inspected returned pen needle.The used pen needle is broken.Defect found added root cause rc-076: mishandled by the end user/mechanical stress-handling.

• 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: 11803067
• Report Number: 1000113657-2021-00309
• Device Sequence Number: 19716694
• Product Code: FMI
• UDI-Device Identifier: 00021292012793
• UDI-Public: (01)00021292012793
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 10/31/2024
• Device Model Number: PNDL, 3BV TVH TP 31G 6MMTC 100CT 30/CS PURPLE
• Device Catalogue Number: S5H01C31-100TC
• Device Lot Number: 9K606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Distributor Facility Aware Date: 04/13/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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