MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309659
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	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 309659.Batch # 4183211.It was reported that the bd luer-lok had foreign matter.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Cst stated they found a syringe that had pieces of plastic inside the syringe.They pulled the entire lot to take precautions as they use these to inject meds into the eye during surgery.Cst does have items that can be sent back.Lot#: 4183211.Product#: 309659.Additional information provided:.Can you please provide an exact date of event in format mm-dd-yyyy? (b)(6) 2024.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No harm, injury, complication, or negative outcome occurred.The issue was found before use on patient and taken out of use.3.Please share the captured photo of the event if available.
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 report for device evaluation and correction.Post investigation findings revealed the additional failure of barrel / flange damaged.It was reported there were pieces of plastic inside the syringe.To aid in the investigation, seven hundred six samples of 1ml luer lol syringes in sealed packaging blisters, material 309649 and lot 4183211, were received for evaluation by our quality team.Six hundred ninety-seven samples had no defects observed.Three samples had damaged to the barrel flange, one syringe had foreign matter outside the fluid path, and five syringes had foreign matter in the fluid path.The conditions observed were non-conforming per product specification and associated with the assembly process.A device history record review was completed for provided material number 309659, lot 4183211.The review revealed all visual inspections were performed per requirements with no quality notifications related to the defect reported.The lot was inspected and accepted based on our inspection control plan and approved for shipment.To date, there have been no other similar events reported for this lot.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.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Post investigation results indicate an additional failure of "barrel / flange damaged".

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• 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: 20956353
• Report Number: 1213809-2024-00967
• Device Sequence Number: 7646353
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597(11)240701(17)290630(10)4183211
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: Health Professional
• Device Catalogue Number: 309659
• Device Lot Number: 4183211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown