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

Catalog Number	305761
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
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 that bd needle eclipse 25x1 rb safety sleeve was difficult to move it was reported by customer that they safety component is in the way when drawing or administering medication, needles are very flimsy and bend easily, seem to cause more site bleeding after administration.Verbatim: 1.Can you please provide an exact date of event in format mm-dd-yyyy? ordered 02/05/2025 , 02/25/2025, 06/18/2025 others were back ordered and then off formulary 2.Could you please provide a further description of the issue? safety component is in the way when drawing or administering medication, needles are very flimsy and bend easily, seem to cause more site bleeding after administration.3.Can you please provide the lot number associated with reported issue? lot# 4330606 lot# 4206638 4.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Needles are very flimsy and bend easily, seem to cause more site bleeding after administration.5.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? xxx.
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.

• Brand Name: ECLIPSE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 22818864
• Report Number: 2243072-2025-01005
• Device Sequence Number: 5713511
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: (01)00382903057610(11)240802(17)290731(10)4206638
• 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: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 4206638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown