MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK LUER-LOK; PISTON SYRINGE

Catalog Number	309658
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
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 euro 200 s/c contained foreign matter.Email ¿ complaint via email.Email(s) attached.Quality received a product complaint from the consumer stating the patient noticed that there was a brown substance dried on the inside of the syringe.The date reported is 08-feb-2026.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.One sample and two photos of a 3 ml eurographic syringe, part number 309658, were received and evaluated.The loose sample exhibited a single brownish yellow discoloration mark embedded within the barrel in a non fluid path area.Both photos, including a close up image, showed the loose syringe with the discoloration as described.This condition is considered non conforming to product specifications.As part of the investigation, a molding process engineer confirmed the defect as embedded foreign matter, and a review of technical and electrical logs identified no issues related to the observed condition.The potential root cause of the defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic, which may occur when resin is exposed to prolonged high temperatures within the molding machine, such as during start up.This defect is cosmetic in nature and does not pose a risk to the customer.A device history record review was completed for material number 309658, lot 4025414.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and is compliant with applicable product specifications.

• Brand Name: BD PLASTIPAK LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24650664
• Report Number: 1213809-2026-00143
• Device Sequence Number: 18602500
• Product Code: FMF
• UDI-Device Identifier: 00382903096589
• UDI-Public: (01)00382903096589(11)240125(17)290131(10)4025414
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: Other
• Device Catalogue Number: 309658
• Device Lot Number: 4025414
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown