MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305780
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
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 1ml ll w/ndl eclipse 25x5/8 rb had foreign matter there is contamination inside the syringe.
Additional Manufacturer Narrative
Our quality engineer inspected the representative sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed a brown embedded foreign matter on the syringe barrel near the scale marking 0.1 and 0.5 ml.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 1ml syringe part is purchased from bd canaan.Bd canaan was notified of this complaint for investigation.Potential root cause for the foreign matter embedded defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start-up.This type of defect is cosmetic and does not pose a risk to the customer.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 representative samples submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the samples.Analysis of the samples showed a brown embedded foreign matter on the syringe barrel near the scale marking 0.1 and 0.5 ml.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 1ml syringe part is purchased from bd canaan.Bd canaan was notified of this complaint for investigation.Potential root cause for the foreign matter embedded defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start-up.This type of defect is cosmetic and does not pose a risk to the customer.

• Brand Name: BD SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 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: 22371671
• Report Number: 2243072-2025-00815
• Device Sequence Number: 11859252
• Product Code: FMI
• UDI-Device Identifier: 00382903057801
• UDI-Public: (01)00382903057801(11)240724(17)290630(10)4176374
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

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: 305780
• Device Lot Number: 4176374
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 09/17/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/11/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown