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	04/21/2026
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd syringe oral 3ml amber contained foreign matter.10mg (number of units inspected: (b)(4); syringe printing defect: 6; plunger rubber stopper defect: 3; scratch: 1) 7.5mg (number of units inspected: (b)(4) syringe printing defect: 1) 5mg (number of units inspected: (b)(4); syringe printing defect: 3; plunger rubber stopper defect: 1; scratch: 1; external surface contamination: 1; adhered foreign matter: 1) 2.5mg (number of units inspected: (b)(4); syringe printing defect: 9; scratch: 1; external surface contamination: 1).Customer response received on 4/30/2026 7:44 pm - (b)(6).Could you please provide the catalogue number of the defective product? 60000310 could you please provide the batch number of the defective product? 5094870 could you please confirm if defects were noticed prior to use? yes was there any patient impact or harm? no ¿ was not administered to any patient as customer had inspected products before usage and found the defect prior.

• 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: 25125590
• Report Number: 1213809-2026-00244
• Device Sequence Number: 8635077
• Product Code: KYW
• UDI-Device Identifier: 30382903052104
• UDI-Public: (01)30382903052104(17)300331(10)5094870
• 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): 06/15/2026

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: 5094870
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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