MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland PEN NDL 32G 4MM 100BX 1200 USA; Needle, Hypodermic, Single Lumen

Model Number	000000000000320122
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Pharmacist reported on behalf of consumer that two of the nano pen needles broke off into the injection site during injection.He stated that the consumer used a pair of pliars to remove the needle from the site.He also stated that there were two separate occurrences.There was no mention of medical intervention.I advised the pharmacist to have the consumer contact us to discuss further.Lot #: 5336026.Catalog #: 320122.Date of event: unknown.Samples: discarded.Vcoyne (b)(6)2026.Update/additional information from nacc - see attachments.(b)(4) - follow up for case (b)(4).This case was created as a follow up to case (b)(4) which was reported by the pharmacist on behalf of the consumer.The consumer called back reporting that there were three to four pen needles that broke off in his injection site.He stated that he was able to remove the needles with the use of a tweezer, and without any medical intervention.There was no injury or discomfort.Samples were discarded, and consumer stated that he does not re-use.
Additional Manufacturer Narrative
Investigation summary: the investigation is currently in progress.Once the investigation is completed, a detailed summary will be provided.

• Brand Name: PEN NDL 32G 4MM 100BX 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: 50059771
• Report Number: 3023359743-2026-00078
• Device Sequence Number: 15733128
• Product Code: FMI
• UDI-Device Identifier: 00383017012236
• UDI-Public: 00383017012236
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/28/2026

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: 000000000000320122
• Device Lot Number: 5336026
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 12/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown