MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND PEN NDL 31GA 8MM 100 BX 1200 USA; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	320109
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
Consumer reported that the needle broke off in his abdomen while doing his injection.He stated that his dog jumped on him while he was injecting, and caused the needle to break off.Consumer stated that he went to the er, and they did an x-ray, ct-scan, and ultrasound, but could not locate the needle.He also stated that he could feel the needle polking his skin when he touches the area.Consumer does not re-use.Lot #: 2277264.Catalog #: 320109.Date of event: unknown.Samples: discarded.
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: b2, b4, g6, h2, h11.Correction to: h1.

• Brand Name: PEN NDL 31GA 8MM 100 BX 1200 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 07054
• MDR Report Key: 23299704
• Report Number: 3023359743-2025-00499
• Device Sequence Number: 4862276
• Product Code: FMI
• UDI-Device Identifier: 00382903201099
• UDI-Public: 00382903201099
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 10/16/2025

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: 320109
• Device Lot Number: 2277264
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown