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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Spouse of consumer reported mixed product, stated that there were pen needles with gray covers in her box of 4mm pen needles.She stated that she discarded the needles when she saw that they were different.She also stated that her husband has never used needles with gray covers.Caller also reported that there were about 20 needles in the same box that were shorter than the 4mm that her husband is using.She believes that the needles are too short and does not go far enough into the skin.I advised consumer that the 4mm pen needles are the shortest and finest needle that we manufacture.Lot #: 3058981 catalog #: 320618 date of event: unknown samples: available - sending mail kit this intake record was reviewed as part of capas #(b)(4) and #(b)(4) and deficiencies were identified.The following actions were taken, "[nineteen additional complaint records were created for dimension.]".With these actions completed, this intake record is now consistent with applicable procedures cp62096, cp92021, and regulatory requirements, and separate complaints were opened for each separate event.There was appropriate follow-up (if this was required), and each event is addressed based on the most current information.No further action is required at this time unless new information becomes available.(b)(4) ¿14sep2026 .
Additional Manufacturer Narrative
20 pen needles affected.

• 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: 50929258
• Report Number: 3027605735-2026-00049
• Device Sequence Number: 21522447
• 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): 09/29/2026

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: 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: 05/10/2024
• Initial Report FDA Received Date: 09/29/2026
• 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