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	01/08/2026
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.
Event or Problem Description
It was reported that bd syringe oral 10ml amber contained foreign matter.During the visual inspection prior to the secondary packaging process at ckk cmo for japan market, the following appearance defections were detected.7.5 mg.Number of units inspected: (b)(4).Acceptable units: 2,392; defective units: (b)(4).Syringe printing defects: 3; plunger rubber stopper defect: 1.10 mg.Number of units inspected: (b)(4).Acceptable units: 1,792; defective units: (b)(4).Syringe printing defects: 2; plunger rubber stopper defect: 1 inner surface contamination or foreign matter: 2.2.5 mg.Number of units inspected: (b)(4).Acceptable units: 3,884; defective units: (b)(4).Syringe printing defects: 2; below the lower limit of fill volume: 3.5 mg.Number of units inspected: (b)(4).Acceptable units: 2,693; defective unit: (b)(4).Plunger rubber stopper defect: 1.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.Multiple photographs of amber syringes in various sizes were received and reviewed.The images depict fully assembled, loose syringes with several observed defects.Five syringes exhibit scale marking issues, including nearly complete absence of markings on four syringes, smeared markings on one syringe, and a skewed scale on another syringe with limited visible markings.Three additional photographs show syringes with stoppers that are not properly seated on the plunger rod, resulting in an insecure stopper condition.The final four photographs, taken from different angles, appear to show the same syringe containing a dark foreign material embedded within the barrel.Based on these observations, the product is considered non conforming to specifications.The likely root causes are associated with the marking process for the scale printing defects, the assembly process for the stopper issue, and the molding process for the embedded foreign material.A quality alert will be issued to the manufacturing plant.Additionally, a device history record review was completed for lot numbers 4309220 and 5094872.The review did not identify any rejected inspections or quality issues during production that may have contributed to the reported defects.Complaints related to this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and the collected data will be regularly reviewed by the business team to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 24308303
• Report Number: 1213809-2026-00053
• Device Sequence Number: 9471261
• Product Code: KYW
• UDI-Device Identifier: 30382903052104
• UDI-Public: (01)30382903052104(17)291031(10)4309220
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: UNKNOWN
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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