MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE ECLIPSE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305762
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 23x1 rb - foreign matter.It was reported by customer that they found debris inside one of their bd eclipse needles.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed a loose gray/ black foreign matter in the packaging.Fourier transform infrared spectroscopy (ftir) was performed to determine the foreign matter type.The results indicated that the spectrum was likely to be a mixture of polypropylene with other unknown 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 have been reviewed, and this batch meets our manufacturing specification requirements.The manufacturing process was reviewed.The manufacturing process is automated, with minimum human intervention, so it is unlikely that the foreign matter was introduced by the operators.Controls are currently in place to minimize foreign matter on products and all machines on the production line are fully covered.Surfaces that are in contact with products are cleaned periodically per the cleaning schedule.Based on ftir analysis, the foreign matter was found to be a mixture of polypropylene and other unknown materials.The actual source of the foreign matter could not be identified.

• Brand Name: NEEDLE ECLIPSE 23X1 RB
• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22860617
• Report Number: 2243072-2025-01041
• Device Sequence Number: 7750752
• Product Code: FMI
• UDI-Device Identifier: 00382903057627
• UDI-Public: (01)00382903057627(11)250116(17)291231(10)5016087
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: 305762
• Device Lot Number: 5016087
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown