MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE ORAL 10ML CLEAR; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	305219
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe oral 10ml clear contained foreign matter.Verbatim: complaint via phone.Pir attached.Case description: a customer reported the presence of an oily substance in the plunger area, specifically at the tip of the syringe.This issue has been observed in approximately 300 units, affecting both the 5ml and 10ml oral syringes.The customer expressed uncertainty about whether this condition is normal or expected.Product: 10 ml bd clear oral syringe | 5 ml bd clear oral syringe ref#: 205219 10ml | 305218 5ml lot#: 6022380 | 5094919.
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.

• Brand Name: BD SYRINGE ORAL 10ML CLEAR
• 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: 25356436
• Report Number: 1213809-2026-00286
• Device Sequence Number: 9966794
• Product Code: KYW
• UDI-Device Identifier: 30382903052197
• UDI-Public: (01)30382903052197(11)260122(17)301231(10)6022380
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 305219
• Device Lot Number: 6022380
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• 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