MAUDE Adverse Event Report: EMBECTA MEDICAL II LLC AUTOSHIELD DUO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	329515
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While attempting to screw needle onto the end of the insulin pen, the spring came out and device fell apart.

• Brand Name: AUTOSHIELD DUO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): EMBECTA MEDICAL II LLC; 300 kimball drive; parsippany NJ 07054
• MDR Report Key: 24589504
• Report Number: 24589504
• Device Sequence Number: 5724702
• Product Code: FMI
• UDI-Device Identifier: 00383017951535
• UDI-Public: (01)00383017951535
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026
• Report Date (Section F): 01/23/2026

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: 329515
• Device Catalogue Number: 329515
• Device Lot Number: 5226013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/23/2026