MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE ECLIPSE 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305764
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
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
Customer states that during destructive testing, 2 vials have been identified as containing cellulose fibers/particulate matter.These pms were identified after reconstitution testing was performed using the bd 21-gauge needle.Reconstitution testing was performed in a laf hood, which was run for 30 minutes and cleaned prior to introducing testing materials.Visual inspection was performed on the reconstitution solution which received passing results.A flush of the needle is performed into a waste container prior to inserting the needle into the sample stopper.After the vials are reconstituted, visual inspection for visible particulates is performed.It was noticed while unpackaging on the needles, material from the backing of the packaging "flaking" off and potentially able to become lodged in the needle.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of packaging damaged/ defective was confirmed upon inspection of the photos.Foreign matter was not able to be confirmed from the photos.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.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the photos.A fourier transform infrared analysis (ftir) report was received for investigation showing 1 foreign matter shaped as a fiber-like object and another foreign matter irregularly shaped.The ftir identified the fiber-like foreign matter as cotton fiber and irregularly shaped foreign matter as cellulose.No similar foreign matter complaints were reported for the affected lot.Investigation confirmed that the cotton fiber did not originate from the manufacturing facility, as no cotton material is used in the machine or its surrounding area.Additionally, simulation demonstrated that if cellulose foreign matter were generated during package opening, the needle shield would prevent entry into the cannula.The foreign matter was likely introduced outside the manufacturing facility during product handling.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.

• Brand Name: NEEDLE ECLIPSE 21X1 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23438166
• Report Number: 2243072-2025-01329
• Device Sequence Number: 20970507
• Product Code: FMI
• UDI-Device Identifier: 00382903057641
• UDI-Public: (01)00382903057641(10)2069746
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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: 305764
• Device Lot Number: 5069746
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 11/18/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/07/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown