MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 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
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 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
Mfr report # 9614033-2026-00026 was submitted as the site legal name was incorrectly reported as canaan in the initial mdr submission, 1213809-2025-00608.Mfr report # 9614033-2026-00026 was submitted to update the site legal name to cuautitlan, and to have the proper mfr number.

• Brand Name: BD SYRINGE 10ML L
• 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: 23092003
• Report Number: 1213809-2025-00608
• Device Sequence Number: 15880709
• 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,Followup
• Report Date (Section B): 04/28/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 04/29/2026
• 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
• Patient Sex: Unknown