MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ORAL SYRINGE; SYRINGE ORAL 3ML AMBER

Catalog Number	305210
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd oral syringe had foreign matter.The following information was provided by the initial reporter: "i'd like raise a complaint regarding particles found in two syringe barrels on the plungers reported by our client in japan.Their analysis reported the particles as polyethylene in one syringe and polyurethane in the when analyzed by ftir, and elemental analysis showed high levels of silicon.Could you please investigate and report within 30 days." bd catalog no 305210.Lot 2343071 & 2333095 (both lots used for packing the product lot in question).
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.D.4.Other lot number includes 2343071.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.H.4.Other lot number device manufacture date is 2022-12-09.
Additional Manufacturer Narrative
Investigation results: two photos of a 3ml amber oral syringe were received by bd.A quality engineer was able to examine the photos from batches 2343071 and 2333095 regarding item 305210.Both images show one loose syringe from different sides with an unknown white particulate on the tip of the stopper in the fluid path.The size of the foreign matter cannot be determined from the photos provided.The condition observed is non-conforming per product specification.Potential root cause for the foreign matter fluid path defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.A device history record review was completed for provided lot number 2343071 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.A device history record review was completed for provided lot number 2333095 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.
Event or Problem Description
No additional information.

• Brand Name: BD ORAL SYRINGE
• Common Device Name: SYRINGE ORAL 3ML AMBER
• 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: 18890766
• Report Number: 1213809-2024-00162
• Device Sequence Number: 11512596
• Product Code: KYW
• UDI-Device Identifier: 50382903052108
• UDI-Public: (01)50382903052108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NA
• 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): 10/16/2024

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: 2333095
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown