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

Catalog Number	309605
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 10ml ll tip bulk convenience pak contained foreign matter.Rcc received a complaint via email.Please see the attached image(s) and details of reported defective material: dmr # (b)(4), po #: (b)(4).Defect material description: syringe tray, 10ml bd 20pk (ref.309605) lot number: 5274495 and 5275045, item code: 309605, defective quantity: 1 ea.Defect description: brown particulates being imbedded in the plastic of the syringe barrel wall.Observed date: (b)(6) 2026.Observed during which process stage: market ir/ dmi number if launched: sample availability for supplier to investigate: yes, is defective evidence (i.E.Pictures, test results etc.) available? yes, is patient impacted? no, if defect has been reported to third party? no, if the defect report from quva customer? no, is there a trend observed? no.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.One sample and four photos of a 10ml luer lok syringe (part number 309605) were received and evaluated.The sample exhibited nine brownish discoloration spots on the barrel, consistent with embedded foreign matter.All four photos, taken from different angles, show the same brownish discoloration on the barrel.This condition is non conforming to product specifications.The potential root cause is associated with the molding process, with the embedded foreign matter most likely being degraded plastic resulting from prolonged exposure of the resin to high temperatures during molding, such as during start up.This defect is cosmetic in nature and does not pose a risk to the customer.Furthermore, a device history record review was completed for the provided lot numbers 5274495 and 5275045.The review identified no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints received for this device and the reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and the collected data will be regularly reviewed by the business team to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD 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: 24330040
• Report Number: 1213809-2026-00063
• Device Sequence Number: 9791350
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054(17)300930(10)5274495
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 03/25/2026

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: 309605
• Device Lot Number: 5274495
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• 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: 10/01/2025
• 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