MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 0.3ML 31G 6MM S/C U-100 RELION; Syringe, piston

Model Number	328521
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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
Consumer reported found 2 syringes from this box with needle thru the needle shields.1 syringe of the 2 syringes like this stuck her finger today.No medical attention was needed.Syringe was unused.Dc.Lot # 4282059 catalog# 328521 date of event 05.12.2025 awaiting sample date of event 05.07.2025 discard sample status awaiting sample caller has photos of today's syringe will send to this case # the photos.(b)(6), (b)(6) 2025.Additional information.See attached both syringes have the needle thru shield the one that stuck her, thru the shield, (b)(6) 2025.Consumer reported found 2 syringes from this box with needle thru the needle shields.1 syringe of the 2 syringes like this stuck her finger today.No medical attention was needed.Syringe was unused.Dc lot # 4282059 catalog# 328521 date of event 05.12.2025 awaiting sample returning with mailing kit 1 syringe date of event 05.07.2025 discard ¿ 1 syringe from this box.Caller has photos of today's syringe will send to this case # the photos update caller does not have ability to email photos at this time.

• Brand Name: SYRINGE 0.3ML 31G 6MM S/C U-100 RELION
• 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: 22161278
• Report Number: 3024508819-2025-00249
• Device Sequence Number: 15324566
• Product Code: FMF
• UDI-Device Identifier: 00681131138383
• UDI-Public: 00681131138383
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• 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): 06/06/2025

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: 328521
• Device Lot Number: 4282059
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female