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

Model Number	320550
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer left voicemail reporting defective needles.Rep returned his call and left voicemail requesting return call.Consumer returned call and reported that needle is protruding through the green inner shield.He stated that he has 17 pen needles where the needle came through the inner shield.Consumer stated that he stuck his finger with the needles a few times.I asked consumer about re-shielding after use and he said that he does not re-shield with the green cover but he prepares the insulin and puts it into the refrigerator for use when it is time to take his injection.Consumer is new to using pen needles and did not seem very sure of how to use.He stated that he does not re-use.Lot #: 3276406.Catalog #: 320550.Date of event: unknown.Samples available: sending mail kit.

• Brand Name: PEN NDL 32G 4MM PRO 100 BOX 1200 US
• 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: 50943410
• Report Number: 3023359743-2026-00645
• Device Sequence Number: 16063825
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 09/30/2026

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: 320550
• Device Lot Number: 3276406
• 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: 09/04/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White