MAUDE Adverse Event Report: EMBECTA MEDICAL DEVICES (SUZHOU) CO., Ltd., China PN RELION 31G X 8MM 3B TW 50CT; Needle, Hypodermic, Single Lumen

Model Number	320616
Medical Device Problem Codes	Off-Label Use (1494); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Dog pet owner reported used about 25 pen needles from this box and realized dog was not getting his insulin.Does not complete a flow check.Dog went into ketoacidosis.Had medical attention and is fine now.Caller has the pen needles.Sending mailing kit.--dog was in hospital for 2 days about a month ago with iv fluids and another medication to help dog eat food.They increased insulin dose from 2 units twice a day to 4 units twice a day.Dog weight is 15lbs.Dc.Lot # 2279565.Catalog# 320616 relion pen needle.Date of event unknown.Sample status awaiting sample.
Additional Manufacturer Narrative
25 pen needles affected in this event, medwatch section c for the affected product is attached.

• Brand Name: PN RELION 31G X 8MM 3B TW 50CT
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): EMBECTA MEDICAL DEVICES (SUZHOU) CO., Ltd., China; CH
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 50948368
• Report Number: 3027605735-2026-00081
• Device Sequence Number: 18729111
• Product Code: FMI
• UDI-Device Identifier: 00681131386814
• UDI-Public: 00681131386814
• 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): 09/30/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 320616
• Device Lot Number: 2279565
• 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: 05/31/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown