MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE ECLIPSE 23X1-1/2 RB TW; SYRINGE

Catalog Number	303304
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported by customer that they go to engage the protective guard, the guard it is popping off or the needle is coming off the syringe.The nursing team has reported to me recent issues with the 23 g bd eclipse needle.They are stating when they go to engage the protective guard, the guard it is popping off or the needle is coming off the syringe.Can we take a look at this? please see the lot and product information below: bd eclipse needle 23g 11/2.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and 15 representative samples submitted for evaluation.The reported issue of safety shield broke off was not confirmed upon inspection of the samples.Analysis of the samples showed no damage or defects.The samples were subjected to an activation and locking force test per procedure and all samples passed with no abnormalities observed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the defect was not replicated.

• Brand Name: NEEDLE ECLIPSE 23X1-1/2 RB TW
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24378832
• Report Number: 2243072-2026-00108
• Device Sequence Number: 10279659
• Product Code: FMI
• UDI-Device Identifier: 00382903033041
• UDI-Public: (01)00382903033041(10)5206106
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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 Catalogue Number: 303304
• Device Lot Number: 5206106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown