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 Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
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-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.
Event or Problem Description
Consumer is reporting "needle break" when taking injections, (the patient end) stated, with most of the boxes he's received in the last two years, he has experienced the issue, (could not provide lot or how many boxes have been used for the last two years).Stated, he is able to remove the needles from his body when they break off.Stated, he does not re-use and rotates the different injection sites, stated, he has been using the product for over 40 years and never had any problems until 2 years ago.This is the first time the consumer is calling in to report the problem.Stated, the quality has gone down with the product and the needles are too thin.Stated, no injury to report, lot: 2123114, catalog: 328203, date of event: unknown, samples: yes.

• 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: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 21914996
• Report Number: 3023359743-2025-00311
• Device Sequence Number: 7135921
• Product Code: FMI
• UDI-Device Identifier: 00382903282036
• UDI-Public: 00382903282036
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• 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): 04/25/2025

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: 328203
• Device Lot Number: 2123114
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White