MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND PEN NDL 29GA 12.7MM 100 BX 1200 USA; Needle, hypodermic, single lumen

Model Number	328203
Medical Device Problem Codes	Break (1069); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The consumer reported the "patient end" of the pen needle broke off in her stomach after injection.Stated, she does not re-use pen needles.Stated, she rotates the different injection sites.Stated, she could not remove it herself so she went to the emergency room, ((b)(6) 2025) stated, the needle was located after an x-ray was performed.Stated, she had surgery to remove the needle on (b)(6) 2025 but the procedure was unsuccessful.Stated, her discharge instructions were to keep an eye out if anything changed with the injection site.Stated, she's been using the product for over 20 years and never had an issue.Lot: 4269020.Catalog: 328203.Expiration date: 2029-09-30.Date of event: 2025-11-07.Emergency room- (b)(6) 2025.Surgery date: (b)(6) 2025.Sample: no.

• Brand Name: PEN NDL 29GA 12.7MM 100 BX 1200 USA
• Common Device Name: Needle, hypodermic, single lumen
• Manufacturer (Section D): EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND; EI
• Manufacturer Contact: anna garbowska-zakrzewski ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 23959496
• Report Number: 3023359743-2026-00001
• Device Sequence Number: 5611827
• Product Code: FMI
• UDI-Device Identifier: 00382903282036
• UDI-Public: 00382903282036
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: Lay User/Patient
• Device Model Number: 328203
• Device Lot Number: 4269020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White