MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL EUROGRAPHICS; PISTON SYRINGE

Catalog Number	303346
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
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
Material #:300912 batch#:4295747.It was reported that the bd syringe 10ml ll eurographics had foreign matter.The following information was provided by the initial reporter: the syringe in the attachment has a foreign substance on the top near the handle.We have found 2 of these from the same lot# and i have 1 of them in my possession.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr/correction - foreign matter.Correction: following submission of initial mdr, the device manufacture date was not correctly reported.Section h updated to reflect correct device manufacture date evaluation: one sample and one photo were provided to our quality team for investigation.A visual inspection was performed, and multiple, brown-colored embedded spots were observed on the barrel flanges.The potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter observed in the sample 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 risk to the customer.These conditions are occurring below their expected frequency.Therefore, no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 4295747.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 10ML LL EUROGRAPHICS
• 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: 21389694
• Report Number: 1213809-2025-00098
• Device Sequence Number: 8595687
• Product Code: FMI
• UDI-Device Identifier: 00382903033461
• UDI-Public: (01)00382903033461(11)241021(17)290930(10)4295747
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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): 03/19/2025

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: 303346
• Device Lot Number: 4295747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown