MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 0.5ML 30GA TW 8MM BLS 400 SG; SYRINGE, PISTON

Model Number	305934
Medical Device Problem Codes	Low Sensing Threshold (2575); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After injection, the locking arm cannot cover the needle and the needle is crooked.Needle stick by the nurse.Sample availability: yes.Sample availability details: picture/video available and physical sample.
Additional Manufacturer Narrative
Additional information was added to: b4, g6, h2, h3, h11.Correction to: h6 (component code, investigation findings, and investigation conclusions).Investigation summary: samples and photo(s) provided.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.Embecta was able to duplicate or confirm the indicated issue as bent cannula and based on trend analysis no further action is required at this time.No definitive root cause determined at this time.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 situation analysis (sa) is required at this time.

• Brand Name: SYRINGE 0.5ML 30GA TW 8MM BLS 400 SG
• 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: 22482373
• Report Number: 3024508819-2025-00265
• Device Sequence Number: 18267304
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2026

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: Health Professional
• Device Model Number: 305934
• Device Lot Number: 3346042
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/29/2025; 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: Asian