MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 21X1-1/2 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305765
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 21x1-1/2 rb tw had foreign matter during the production process, a dirty cannula with black particles was discovered, please see the following pictures.This concerns your batch 4126045.To facilitate our internal evaluation, we kindly request information regarding your awareness of this defect and whether any similar analyses or potential causes have been investigated in the past.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed a crack on the surface of the needle shield.The contamination could not be determined to be loose or embedded.The foreign matter was brown and inside the needle shield.Fourier transform infrared spectroscopy was performed to determine the foreign matter type.The foreign matter is most likely an unknown organic material.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Based on the foreign matter type, investigation was conducted on the potential sources.The molding, assembly and packaging process has been reviewed; no possible source of the organic compound can be found.The root cause could not be determined.

• Brand Name: BD NEEDLE ECLIPSE 21X1-1/2 RB TW
• 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: 21405380
• Report Number: 2243072-2025-00104
• Device Sequence Number: 18505643
• Product Code: FMI
• UDI-Device Identifier: 00382903057658
• UDI-Public: (01)00382903057658(11)240506(17)290430(10)4126045
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

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: 305765
• Device Lot Number: 4126045
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 05/29/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/19/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown