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

Catalog Number	305761
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.3.Franklin lakes has been listed as the manufacturer.G.1.Franklin lakes has been listed as the manufacturer.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 that the bd needle eclipse 25x1 rb safety shield broke off.The following information was provided by the initial reporter: material # 305761 batch # 4361973 verbatim: per report: the employee who was working in a flu drive at the **** in temple on (b)(6) told me that when she activated the safety on the needle, the needle went through the cap.She said about 20 minutes later, another staff member using needles from the same lot# also had a similar incident; and 2 other staff members had the safety fall off completely.------------------------------------- customer responded on 14-oct 1.Please share the material & lot number associated with reported issue - bd eclipse needle 25 x 1in lot # 4361973.2.Describe any patient harm, injury, complication, or negative outcome that occurred as a result of the event.¿ employee was injured via needlestick and exposed to a patient¿s blood and bodily fluid.Other employees reported the safety fell off.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
Describe any patient harm, injury, complication, or negative outcome that occurred as a result of the event.¿ employee was injured via needlestick and exposed to a patient¿s blood and bodily fluid.Other employees reported the safety fell off.
Additional Manufacturer Narrative
(b)(4) follow-up report for correction.Annex e code updated to e2010 - needle stick/puncture.Annex f code updated to f11 - non-serious injury/illness/impairment.

• Brand Name: ECLIPSE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 23439909
• Report Number: 2243072-2025-01331
• Device Sequence Number: 17301363
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: (01)00382903057610(11)250106(17)291231(10)4361973
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025

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: Health Professional
• Device Catalogue Number: 305761
• Device Lot Number: 4361973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: Not provided; 11/12/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/11/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown