MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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 syringe 3ml ll w/ndl eclipse 25x1 rb had foreign matter.It was reported by the customer that they had a sticky substance in the syringe.Rcc received a complaint via phone.Product complaint: customer called to report, while using trying to draw up air she noticed the bd syringe ref: 305787, lot: 4043533, had a sticky substance in the syringe.Not used on a pt, no pt harm, sample available, doe on 02/05.
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 sticky substance on the sample.The substance was determined to be excessive amounts of silicone.The sample was subjected to a silicone content test and the sample failed the functional test.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.The root cause for the foreign material is due to intermittent poor relay feedback from the slip ring to the silicone gun during production.Action had been taken to replace the old slip ring to address the issue of poor signal relay to the silicone gun.The replacement was done on (b)(6) 2024.The syringe batch is produced in feb 2024 which is before the action implementation.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21434309
• Report Number: 2243072-2025-00124
• Device Sequence Number: 17275196
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: (01)00382903057870(11)240224(17)290131(10)4043533
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/27/2025

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: 305787
• Device Lot Number: 4043533
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown