MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND PEN NDL 32G 4MM PRO 90CT US; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	320574
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported, the non-patient end broke off in insulin pen when trying to remove pen needle after injection.1 pen needle affected.No injury to report; mail kit and replacement box; event date sept 21, 2024; sample status awaiting sample cl.
Additional Manufacturer Narrative
Correction to: h6 (component code, type of investigation, and investigation conclusions) 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.

• Brand Name: PEN NDL 32G 4MM PRO 90CT US
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 20471141
• Report Number: 3023359743-2024-00565
• Device Sequence Number: 7255103
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K212015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2026

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: 320574
• Device Lot Number: 3290786
• Was Device Available for Evaluation?: Yes
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/17/2024; 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White