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

Model Number	PNDL, 5BV TVH TP 31G 8MM100CT 30/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Products were returned and pending qc evaluation.Note: manufacturer contacted customer in a follow-up call on 28-oct-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for bent pen needles.Customer stated that she used the needles for the past few days and about three of them were bent when she tries to administer her injection.Customer states that when she inserts the needle in her stomach it moves around, and she is scared that the needle will come off while in her stomach.Customer stated she received the pen needles on 09/20/2020.Customer was unable to verify the lot # or any information on the package of the pen needles stating that the pharmacy gives her them to her 30 at a time in a prescription bottle.Customer stated that she was getting them in the box but for the last 2-3 months, the pharmacy removes them and puts them in a prescription bottle.Customer was only able to verify that the pen needles are 31 gauge.The customer feels well and did not report any symptoms.Customer did not claim to be injured using the pen needles and no medical intervention related to the use of the pen needles was reported.Pharmacy was contacted on 10/14/2020 and confirmed that the customer is on state insurance and that all it would cover is 30 pen needles at a time.Pharmacist stated that they have to break the box and give the customer 30 pen needles each time.The pharmacist was able to verify: lot # 8f600, expiration date of may 2023.
Additional Manufacturer Narrative
Sections with additional information as of 12-dec-2020: h3: device evaluated by manufacturer: yes.H6: updated fda's method, result, and conclusion codes.H10: product evaluated by manufacturer and no defect found.Mlc-009: use error caused or contributed to event.

• Brand Name: PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10810172
• Report Number: 1000113657-2020-00816
• Device Sequence Number: 3799391
• Product Code: FMI
• UDI-Device Identifier: 00021292010799
• UDI-Public: (01)00021292010799
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/12/2020

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: 05/31/2023
• Device Model Number: PNDL, 5BV TVH TP 31G 8MM100CT 30/CS
• Device Catalogue Number: S6H01D31-100
• Device Lot Number: 8F600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Distributor Facility Aware Date: 10/13/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1