MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	329515
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report (b)(4) attached to this case.Unable to open the report lot # unknown catalog# unknown date of event unknown at this time sample status no.(b)(6), (b)(6) 2026: as per the attached report.Describe the event or problem: rn administering insulin sq [sub-cutaneous] to patient.Needle did not self-retract.Needle stick injury to writer.What was the original intended procedure: inject insulin and prevent staff needle stick what problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working); device malfunction - that is, the device did not do what it was supposed to do.Vcoyne (b)(6) 2026 update/additional information from nacc - see attachments.Lot # 4311022 event needle stick to staff after injecting patient."needle did not self-retract.Needle stick to writer after injection" medwatch report (b)(4).Describe the event or problem: rn administering insulin sq [sub-cutaneous] to patient.Needle did not self-retract.Needle stick injury to writer.What was the original intended procedure? inject insulin and prevent staff needle stick-- what problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working) ; device malfunction - that is, the device did not do what it was supposed to do.
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.
Additional Manufacturer Narrative
Additional information was added to: b4, g6, h2.Correction: h10.

• Brand Name: PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
• Manufacturer Contact: anna garbowska-zakrzewski ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 24366932
• Report Number: 3023359743-2026-00006
• Device Sequence Number: 5315513
• Product Code: FMI
• UDI-Device Identifier: 00383017951535
• UDI-Public: 00383017951535
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 329515
• Device Lot Number: 4311022
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown