MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland PEN NDL 31GA 5MM 100BX 1200 USA; Needle, Hypodermic, Single Lumen

Model Number	320119
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported, no insulin flow when taking injection.12 pen needles affected.Stated, does not prime before attempting injection because she does not want to waste the medication.Stated, once, the patient end on the pen needle was missing prior to injection.Lot: 3304314 catalog: 320119 date of event: unknown samples: no cl.

• Brand Name: PEN NDL 31GA 5MM 100BX 1200 USA
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland; EI
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 50941585
• Report Number: 3023359743-2026-00615
• Device Sequence Number: 10756341
• Product Code: FMI
• UDI-Device Identifier: 00382903201198
• UDI-Public: 00382903201198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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 Model Number: 320119
• Device Lot Number: 3304314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White