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

Catalog Number	305207
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe oral 1ml amber demonstrated a volumetric accuracy issue.It was reported that 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: (b)(4); defective units: (b)(4).Syringe printing defects: 3; plunger rubber stopper defect: 1.10 mg number of units inspected: (b)(4) acceptable units: (b)(4); 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: (b)(4); 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: (b)(4); defective unit: (b)(4).Plunger rubber stopper defect: 1.
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.
Additional Manufacturer Narrative
(b)(4) follow up- one photograph of an amber 1ml syringe, part number 305207, was reviewed, showing a fully assembled loose syringe with a scale marking defect characterized by significant smearing of the number 2.Based on this observation, the product is considered non conforming to specifications, and the defect is likely related to the marking process, therefore, a quality alert will be issued to the manufacturing site.The reported defect of volumetric accuracy was not observed and could not be confirmed from the photo provided.In addition, a device history record review for lot number 5100291 identified no rejected inspections or production quality issues that could have contributed to the reported condition.

• 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: 24383075
• Report Number: 1213809-2026-00073
• Device Sequence Number: 13384496
• Product Code: KYW
• UDI-Device Identifier: 30382903052074
• UDI-Public: (01)30382903052074(10)5100291
• 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): 04/15/2026

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: 305207
• Device Lot Number: 5100291
• 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: 04/15/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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