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

Catalog Number	309695
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
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
Material: 309695, batch#: 4088628.It was reported that the bd luer-lok had foreign matter.The following information was provided by the initial reporter: verbatim: i have a defective product to report and have a sample to send back for qc.The reason for the delay in filing is that i had to find the correct person to report it to¿.Date: (b)(6) 2024.Mfg bd.Product bd 10 ml control syringe.Product #309695.Lot# 4088628.Expire 2-28-29.Challenge dirt/mildew inside sterile package.This has not be opened and available to return to bd.Please advise on next steps.Customer responsse: date: (b)(6) 2024, mfg bd, product bd 10 ml control syringe, product # 309695, lot# 4088628, expire 2-28-29, challenge dirt/mildew inside sterile package.There were no adverse event since this was caught before it was opened in the or.This has not be opened and available to return to bd.
Additional Manufacturer Narrative
It was reported there was dirt inside the sterile package.To aid in the investigation, one sample of a 10ml control syringe from lot 4088628 was received and evaluated by our quality team.The syringe received was in an unsealed package and has a reddish-brown foreign matter on the thumb grip.Fourier-transform infrared spectroscopy (ftir) analysis was performed on the foreign particle in an attempt to identify the particle¿s composition.The ftir results were found to be inconclusive.However, the foreign matter is consistent with the grease used at the manufacturing location.Most likely the grease used on the conveyor belt.The condition observed is non-conforming per product specification and is associated with the molding process.A quality alert will be issued to the plant.A device history record review was completed for provided material number 309695, lot 4088628.The review revealed all visual inspections were performed per requirements with no quality notifications related to the defect reported.Lot 4088628 was inspected and accepted based on meeting our inspection control plant and was subsequently approved for shipment.We appreciate you taking the time to bring this observation to our attention.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
No additional information was provided.

• 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: 19736985
• Report Number: 1213809-2024-00453
• Device Sequence Number: 7080945
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955(11)240328(17)290228(10)4088628
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/20/2024

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: Health Professional
• Device Catalogue Number: 309695
• Device Lot Number: 4088628
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 07/13/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown