MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NOT APPLICABLE; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	305210
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd syringe oral 3ml amber contained foreign matter.Syringe oral 3ml amber.Syringe printing defects quantity: 10.Plunger rubber stoper defects quantity: 4.Scratch on syringe quantity: 2.External surface.Contamination quantity: 1.Adhered foreign matter quantity: 1.

• Brand Name: NOT APPLICABLE
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATED
• 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: 25068501
• Report Number: 1213809-2026-00231
• Device Sequence Number: 21437166
• Product Code: KYW
• UDI-Device Identifier: 30382903052104
• UDI-Public: (01)30382903052104
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 305210
• Device Lot Number: 5094872
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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