MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 10ML L; PISTON SYRINGE

Catalog Number	309604
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 10ml ll had forieng matter.The following information was provided by the initial reporter: this is a complaint about poor printing & foreign matter contamination found before use.It was reported that during the visual inspection within the process, customer identified nonconforming products.The defect is ink smudging.This is due to poor printing and foreign matter contamination.
Additional Manufacturer Narrative
Photos and physical samples were received by our quality team for evaluation.Upon evaluation of the photos and physical samples, incomplete markings, damaged plunger, black spots embedded on the plunger, white spots on the cylinder, and improperly assembled cap were all observed.The reported defects could be verified.A device history record could not be evaluated as the lot number is unknown.Based on the quality team's investigation, the root cause for all of the observed failures is related to manufacturing: incomplete scale markings is due to wear on equipment.Damaged plunger is due to the plunger or cylinder becoming stuck during assembly.The black spots are embedded foreign matter that are from material accumulated in the molding machines.The white spots on the cylinder is degraded resin from the injection molding process.The improperly assembled caps is due to low silicone in the cylinder that results in greater force during stopper-plunger-cylinder assembly which causes the stopper to not be assembled correctly.Actions plans have been put in place for all failures to reduce their incidence in the process.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.This is a "new " initial mdr.This report is supplemental to previously submitted 1213809-2025-00608.The product originally was determined to be manufactured by canaan but when the customer provided a lot number, it was determined that the legal manufacturer is cuautitlan.This new mdr is being submitted to correct the legal site and to submit a mdr under the correct site registration number.A correction supplemental was submitted for 1213809-2025-00608 stating the cancellation of the original mdr.

• Brand Name: BD SYRINGE 10ML L
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25020060
• Report Number: 9614033-2026-00026
• Device Sequence Number: 10462589
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: (01)30382903096047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/24/2026

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: 309604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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