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

Catalog Number	305210
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe oral 3ml amber contained foreign matter.We had a complaint raised by a client where it was discovered there were defects on the syringes.Examples were syringe printing defect, plunger rubber stopper defect and inner surface contamination.Please can you investigate into this and provide an investigation report.Material: oral syringe, item code: 60000310, batch number: 5094872, po number: (b)(4).Defect mentioned in the complaint form: during the visual inspection prior to the secondary packaging process at ckk, cmo for japan market, the following appearance defections were detected.10 mg, number of units inspected: 1,797, acceptable units: 1,792, defective units: 5, syringe printing defects: 2, plunger rubber stopper defect: 1, inner surface contamination or foreign matter: 2.
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.
Additional Manufacturer Narrative
(b)(4) follow up: ten photos of 3 ml amber oral syringes (part number 305210) were reviewed.Four syringes showed partially missing scale markings, two syringes had stoppers that were not securely attached to the plunger rod, and four syringes contained an unknown clear fluid with a dark spot on the barrel.Based on the photos, it cannot be determined whether the spot is within the fluid path, non-fluid path, or embedded in the barrel.These conditions are non-conforming to product specifications.The scale marking issue is likely related to the marking process, and the stopper issue is likely related to the assembly process.A root cause for the foreign matter cannot be determined from photos alone, and a physical sample is required for further evaluation.A device history record review for material number 305210, lot 5094872, confirmed that all in process and final visual inspections were completed as required, with no related quality notifications identified.The lot met acceptance criteria, was approved for shipment, and complied with applicable product specifications.

• Brand Name: BD ORAL SYRINGE
• 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: 24334894
• Report Number: 1213809-2026-00065
• Device Sequence Number: 4770557
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 02/24/2026
• 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