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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe oral 3ml amber had foreign matter.The following information was provided by the initial reporter: it was reported that additional issues for the buccolam syringes.Considering the volumes of defects that we were observing in the dosed syringes, one batch of incoming product ad052001 buccolam syringe 3ml lot 100941 has been reviewed.23,000 syringes from batch ad052001, lot 100941, were inspected before being loaded into the dosing machine (directly from the supplier).The following defects were found: syringes with misaligned printing: (b)(4) units syringes with stained plungers: (b)(4) units syringes with broken or cracked plungers: (b)(4) units syringes with a notch in the plunger: (b)(4) units syringes with bent plungers: (b)(4) units find pictures in the attached document.Note that our reference for the case is (b)(4).Before use.
Additional Manufacturer Narrative
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.Six photos of 3 ml amber oral syringes part number 305210 were reviewed, revealing multiple non conforming conditions.The images showed syringes with cracked and bent plunger rods, plunger rod damage affecting multiple units, missing and skewed scale markings, barrel flange damage, and black discoloration on a plunger rod.These observed defects do not meet product specifications.The likely root causes include the molding process for embedded foreign matter, the marking process for barrel damage and skewed scale defects, and the assembly process for damage to the plunger rods.A device history record review was completed for material number 305210, lot 4278622.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and is in compliance 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: 24184863
• Report Number: 1213809-2026-00028
• Device Sequence Number: 18522691
• Product Code: KYW
• UDI-Device Identifier: 30382903052104
• UDI-Public: (01)30382903052104(17)290930(10)4278622
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 4278622
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown