MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS Luer-Lok; Syringe, Piston

Catalog Number	309628
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml ll contained foreign matter.It was reported that a formal complaint received from one of our customers concerning the recurring presence of particles and plastic-like inclusions inside bd 1 ml syringes.Most recently, our customer observed a plastic-like particle inside a 1 ml syringe during the production of prefilled syringes.The particle became visible after the medicinal product had already been filled into the syringe.Upon closer inspection, the particle appeared to be floating freely inside the syringe.According to our customer, this is not an isolated incident.Including the most recent event, a total of nine deviations have been documented within approximately one year involving particles inside these syringes.As the syringes are inspected for air bubbles and particles after production, several affected syringes had to be rejected and remanufactured.The recurring nature of these findings may indicate a manufacturing or quality issue.We therefore kindly request that bd conduct a thorough investigation, including a root cause analysis, and provide us with the results as well as any proposed corrective and preventive actions.The relevant syringe details provided by our customer are listed below: deviation 1: lot#: 3128967, deviation 2: lot#: 3128967, deviation 3: lot#: 4285657, deviation 4: lot#: 50989303, expiry date: 31mar2030, no pictures available.Deviation 5: lot#: 5121479, expiry date: 30apr2030, deviation 6: lot#: 5121479, expiry date: 30apr2030, no pictures available.Deviation 7: lot#: 5353614, expiry date: 30nov2030, deviation 8: lot#: 5162348, expiry date: 31may2030, deviation 9: lot#: 5162348, expiry date: 31may2030.Reference images of the affected syringes and particles, as provided by our customer, are attached to this complaint where available.Please confirm receipt of this complaint and provide us with a complaint reference number.We would also appreciate information regarding the expected timeline for your investigation.Please let us know should you require any additional information, samples, or supporting documentation from us or from our customer.Response received on:7/29/2026 6:50 pm - (b)(6).Could you please provide all the event dates associated with the reported issue? i think this information is not that important, the customer also can't answer it.Response received on:7/27/2026 5:00 pm.Could you please provide the catalogue number(s) of all the defective products? the article number is as stated.Would this be different for any reason? could you please confirm whether any patient or user was harmed? if yes, please provide details.No.The defects were all discovered in the manufacturing process of pre-filled syringes, and never came in contact with patients.Could you please provide all the event dates associated with the reported issue? i highly doubt this is relevant, especially when you have every single batch number available.Regardless, 'including the most recent event, a total of nine deviations have been documented within approximately one year involving particles inside these syringes'.How necessary is it to know the exact dates? the customer may know but if it isn't necessary, i'm not sure its worth bothering them.The syringes are checked for problems (including air bubbles and particles) after production, therefore several products were rejected after manufacture.Bear in mind, the products are pre-filled syringes, so this means that the syringes are rejected with the possibly valuable contents already inside.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
B3.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.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.It was reported that foreign particles and plastic-like inclusions were recurring within bd 1 ml syringes.Thirteen photographs of 1 ml luer-lok syringes (part number 309628) were received and evaluated.The photographs show particulates of varying color, size, and location within the syringe barrels, including white or light-colored, brown or orange, and dark-colored particulates near the stopper and luer-end regions.The particulates appear distinct from the syringe components, stopper assemblies, and printed graduation markings, consistent with the presence of foreign matter.Additionally, three photographs show visible air bubbles within the syringe barrels near the luer end.The observed foreign matter and air bubbles are considered non-conforming per product specification, with the potential root cause associated with the assembly process.A review of the device history records (dhrs) was also completed for material number 309628, lots 3128967, 4285657, 5098930, 5121479, 5353614, and 5162348.All required visual inspections were performed, with no quality notifications identified related to the reported complaint defects.All batches met the applicable inspection control plan requirements, were accepted, and were subsequently approved for shipment.Complaints associated with this device and reported conditions will continue to be tracked and trended, with the data monitored monthly and routinely reviewed by the business team to identify any emerging trends.

• Brand Name: Luer-Lok
• Common Device Name: Syringe, Piston
• 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 ; +1(847)393-5694
• MDR Report Key: 50169549
• Report Number: 1213809-2026-00403
• Device Sequence Number: 9886135
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: (01)00382903096282(17)280430(10)3128967
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 309628
• Device Lot Number: 3128967
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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