MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS; Syringe, piston

Model Number	328418
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-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.
Event or Problem Description
Email: hello all, i hope this email finds you well.I received a message from our customer support team regarding a customer complaint.This is the information i was able to obtain.Customer name: phone: customer states he has been trying to file this complaint for more than a year.The needles are breaking off in his skin and he has to remove them with tweezers.He said this happened a year ago and then again more recently about 2 weeks ago.He states it is not specific to a particular lot number.He also states the needles been upon insertion.He stated he has left multiple messages and has emailed with no response.Based on the information received from customer support, he is threatening to take this to the media/internet if he does not speak to someone.I did speak with the customer and he did not state that in my conversation with him.Please contact him at your earliest convenience.Thank you.(b)(6) 2025.Additional information.I called consumer to follow up on complaint.Consumer stated that over the past year he had issues with several syringes.The most recent issue is from lot # 4290049, product # 328418.Consumer stated that the needles bend during injection.Previous incidents included needles breaking off at the injection site (removed with a tweezer), bubbles under the skin during injection, and needles dull, causing bleeding at the injection site.Consumer does not re-use.Packaging and samples for previous incidents were discarded; lot and product numbers are unavailable.Regarding (b)(4), the correct lot number is 4240049.

• Brand Name: SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
• Common Device Name: Syringe, piston
• Manufacturer (Section D): EMBECTA MEDICAL I LLC - HOLDREGE, NE
• Manufacturer Contact: anna garbowska-zakrzewski ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 23358472
• Report Number: 3024508819-2025-00289
• Device Sequence Number: 8863790
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• 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): 10/22/2025

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: 328418
• Device Lot Number: 4240049
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown