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	Break (1069); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The incident took place in the patients home.Home health care aid stated, she was told by the aid who worked the shift before her, the non-patient end got stuck in the insulin pen after giving the patient an injection.The home health aid after being told about the incident, stabbed her finger with the non-patient end that was sticking out of the insulin pen.Stated, the needle was used and asked if blood could travel from the non-patient end to her finger that was "stuck".Home health aid did not confirm if blood was on the non-patient end before sticking her finger.Declined to send back the samples, stated, she does not feel comfortable packing up the insulin pen with needle sticking out of it but was okay with touching it after she was warned by the previous aid, there was a needle that had broken off and was sticking out from the insulin pen.Stated, she went to her doctor and got a shot just to be safe.Stated, she will email a photo of insulin pen.I provided her the email address and case number.Lot: 4131014.Catalog: unknown-per hcp, "auto shield duo" was being used.Date of event: 2025-02-02.Sample: no.

• Brand Name: PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA
• Common Device Name: Needle, hypodermic, single lumen
• Manufacturer (Section D): EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND; EI
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 21471262
• Report Number: 3023359743-2025-00155
• Device Sequence Number: 14305282
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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: 329515
• Device Lot Number: 4131014
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown