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

Catalog Number	309649
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 the bd syringe 5ml ll euro 125 s/c had foreign matter.The following information was provided by the initial reporter.Hope you are well.We have had several rejections for the bd syringes we have received within the last 3 months.The batch numbers rejected in the above spreadsheet, have been discarded.However, we can provide samples containing contamination, if required.Could you please explain the reason for the rejection? the syringes contained white particles / some had an issue with the plunger.Was patient or user harmed? if yes, please explain no patients were harmed.The particles were identified at the 1st quality check.Was the device being used in/on patient when the issue occurred? no.Could you please explain the event in detail? the syringes go through quality inspection at the point of receipt, if syringes contain particles these are identified at this initial stage.Quality team met with customer on (b)(6) 2025 to further discuss the issue they were experiencing.Per details provided: quantum compounds cytotoxic medications for hospitals using our 3, 5-, 10-, 20- and 50-ml syringes.They use a 0.5 micron filter when compounding.Incoming inspection was performed on syringes by quantum, and small particulate was observed across multiple lots spanning several months (in reference to the excel spreadsheet shared with bd).No magnification is used by quantum or their customer to detect fm.Quantum understands the ink dots on the barrel are deliberately added during manufacturing; this fm is different.It is often located on the internal stopper area and does not appear to be silicone.Previously quantum performed 100% inspection.This level has been reduced and fm is being observed.Previously quantum didn't raise complaints to bd that were reported by their customers and would discard syringe if the occasional fm was found outside the fluid path.Additional information provided: the particles identified were in the barrel, within the fluid pathway.
Additional Manufacturer Narrative
(b)(4).Supplemental mdr: foreign matter.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown; therefore, device history record review (dhr) or quality notification review (qn) could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of 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: 22190172
• Report Number: 1213809-2025-00394
• Device Sequence Number: 21042073
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: (01)30382903096498(11)240328(17)290331(10)4065347
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: Other
• Device Catalogue Number: 309649
• Device Lot Number: 4065347
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 8 MO
• Patient Sex: Unknown