MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL SP125; PISTON SYRINGE

Catalog Number	309646
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
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
It was reported that the bd syringe 5ml ll sp125 had foreign matter.The following information was provided by the initial reporter: material # 309646.Lot # 5112794.Verbatim: rcc received a complaint via email.Email(s) attached.Particulate observed at site of care xxxx per scar - 00051 attachment 1 characterization report the combined morphology.Chemical (ft-ir) and elemental (eds) data indicate that the free-floating particulate observed inside of the breyanzi vial cd8 has consistency with a polyacrylate-based material.When discovered on (b)(6) 2025.Weight limited to one syringe of lot 5112794.Material name - syringe disposable luer-lok 5ml.Vendor manufacturing lot 5112794.Per customer.The defect in this event is from a free-floating particulate which was observed inside a breyanzi cdb cellseal vial.This particulate was observed inside the cd8 cellseal vial at the site of care, which is downstream of the use of the 5ml syringe.The affected product was not administered to the patient the particulate was noticed at the site of care during thawing, prior to inoculation.
Additional Manufacturer Narrative
(b)(4) follow up: a free-floating particulate was reported.To support the investigation, eight photographs were provided for evaluation by the quality team.Four images, taken from different angles, depict an unidentified vial with an attached tip, filled with an unknown cloudy fluid.One image shows a brown particulate, while two additional images present the same particulate under magnification.The final image contains the results of a fourier-transform infrared spectroscopy (ftir) analysis, indicating the most likely material match as ¿polyacrylate-based material.¿ based on the available information, the foreign matter cannot be confirmed as originating from the canaan manufacturing plant.A device history record review was conducted for material number 309646, lot 5112794.The review confirmed that all visual inspections were performed according to requirements, with no quality notifications related to the reported condition.The lot was inspected and accepted in accordance with the inspection control plan, approved for shipment, and deemed compliant with product specification requirements.Technical and electrical logs, as well as the production database, were reviewed and revealed no issues associated with the reported condition.Additionally, all housekeeping tasks were documented as completed throughout the batch run.To date, no similar events have been reported for this lot.

• Brand Name: BD SYRINGE 5ML LL SP125
• 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: 23417735
• Report Number: 1213809-2025-00681
• Device Sequence Number: 8983101
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: (01)30382903096467(10)5112794
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 309646
• Device Lot Number: 5112794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown