MAUDE Adverse Event Report: EMBECTA MEDICAL DEVICES (SUZHOU) CO., Ltd., China PN RELION 32G X 4MM 3B TW 50CT; Needle, Hypodermic, Single Lumen

Model Number	320618
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported, no insulin flow when priming pen needles.5 pen needles affected.Lot: 3058981.Catalog: 320618.Date of event: unknown.Samples: yes cl.
Additional Manufacturer Narrative
5 pen needles affected by event.

• Brand Name: PN RELION 32G X 4MM 3B TW 50CT
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): EMBECTA MEDICAL DEVICES (SUZHOU) CO., Ltd., China
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 50882243
• Report Number: 3027605735-2026-00020
• Device Sequence Number: 21316979
• Product Code: FMI
• UDI-Device Identifier: 00681131386791
• UDI-Public: 00681131386791
• Combination Product (Y/N): N
• 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): 09/24/2026

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: 320618
• Device Lot Number: 3058981
• Was Device Available for Evaluation?: Yes
• 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: 04/04/2024
• Initial Report FDA Received Date: 09/24/2026
• 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: Unknown