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

Catalog Number	305759
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
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 25x5/8 safety sleeve 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: rcc received a complaint via email.We are having issues with the bd eclipse needles in 3 other clinic locations in xxx.I am including them on this email, and i am hopeful that you can reach out to them and get the information that you need.Xxx, if you could reach out to them with the education info and any other helps, i would appreciate it.25g needle b-d305759 xxx is at the xxx xxx; 25g needle, new i haven¿t received word on which specific model yet.Xxx is at xxx xxx hub needle combo.Is at customer response on 30-jul-2025.1.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?.
Additional Manufacturer Narrative
Our quality engineer inspected the photo and 3 samples submitted for evaluation.The reported issue of safety sleeve difficult to move was not confirmed upon inspection of the samples.Analysis of the samples showed no damage to the hub luer surface.Samples were subjected to a hub leak test and no leak was observed.A safety shield inspection was also completed to check for hub hook breakage and no damage was 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: 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: 22784366
• Report Number: 2243072-2025-00981
• Device Sequence Number: 15517991
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: 305759
• Device Lot Number: 4330606
• 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: 07/27/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown