MAUDE Adverse Event Report: EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA PN RELION 31G X 6MM 3B TW 50CT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	320617
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Family member of consumer reported that the pen needle will not attach to the insulin pen.I reviewed the steps with consumer and she was able to secure the needle onto the pen.Consumer is new to using pen needles.Lot #: 3096247, catalog #: 320617, date of event: unknown, samples: discarded.
Additional Manufacturer Narrative
Correction to: h6 (type of investigation and investigation conclusions).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-conformance's 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: PN RELION 31G X 6MM 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: 20078776
• Report Number: 3027605735-2024-00059
• Device Sequence Number: 20746293
• Product Code: FMI
• 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,Followup,Followup
• Report Date (Section B): 08/25/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 320617
• Device Lot Number: 3096247
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/11/2024; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown