MAUDE Adverse Event Report: BECTON DICKINSON BD ECLIPSE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	305757
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: during the infant receiving the vitamin k injection, when the needle was removed from the left thigh it was noted to be at almost a 90-degree angle and when removed rn did not know the needle had bent while in the muscle and when removed the needle scratched the infant's thigh.The device information provided is from a "like" device.The device involved in this event has been discarded by staff.

• Brand Name: BD ECLIPSE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• MDR Report Key: 24290614
• Report Number: 24290614
• Device Sequence Number: 9426528
• Product Code: FMI
• UDI-Device Identifier: 00382903057573
• UDI-Public: (01)00382903057573
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 02/05/2026
• Report Date (Section F): 02/05/2026

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: 305757
• Device Catalogue Number: 305757
• Device Lot Number: 5246027 (FROM A LIKE DEVICE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• 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 Age: 1 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Date Report Sent to FDA: 02/05/2026