MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland PEN NDL 32G 4MM PRO 90CT US; Needle, Hypodermic, Single Lumen

Model Number	320574
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Email did not go into salesforce.Had to copy and paste the complaint.First time contacting.Been using nano pen needles for years, know needles delicate and needles are often faulty , meaning won¿t dispense insulin.My current box is a joke , last night , four in a row of trying to inject insulin wouldn¿t work!! lot 4317041 ref (b)(4) date of event: 2025-10-11 4 pen needles affected on that day samples: no.
Additional Manufacturer Narrative
This medwatch submission is both an initial and supplemental filing.Investigation of the results can be seen below: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: PEN NDL 32G 4MM PRO 90CT US
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland; EI
• Manufacturer Contact: anna garbowska-zakrzewski ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 50898778
• Report Number: 3023359743-2026-00237
• Device Sequence Number: 5829475
• Product Code: FMI
• UDI-Device Identifier: 30383017057436
• UDI-Public: 30383017057436
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Device Model Number: 320574
• Device Lot Number: 4317041
• 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: 09/11/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown