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

Catalog Number	309649
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
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 5ml ll euro 125 s/c contained foreign matter.Verbatim: i work in the pediatric department at (b)(6) hospital, and we have found a luer lock syringe that has some kind of spots, even though it is sterilely packaged.I am attaching pictures with the batch number as well as pictures of the spots.There are two brownish spots in two different places.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.One sample and three photographs of a 5 ml eurographics syringe (part number 309649), batch 4352949, were received and evaluated.The sample was received in a sealed package with all required product information.Inspection identified two brownish discoloration spots on the barrel, consistent with embedded foreign matter.One photograph shows the top web of the package with product information, and the remaining two photographs show the syringe within the package, each clearly depicting the brown spots on the barrel.This condition is considered non conforming per product specifications.The embedded foreign matter is most likely degraded plastic associated with the molding process, which can occur when resin is exposed to elevated temperatures during start up.This is a cosmetic defect and does not present a risk to the user.Furthermore, a device history record review was completed for the provided lot number 4352949.The review identified no rejected inspections or quality issues during production that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints related to this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and the business team will regularly review the collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: 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: 24338833
• Report Number: 1213809-2026-00067
• Device Sequence Number: 20052780
• Product Code: FMF
• UDI-Device Identifier: 00382903096497
• UDI-Public: (01)00382903096497(11)241217(17)291130(10)4352949
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 309649
• Device Lot Number: 4352949
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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