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

Catalog Number	309695
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	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 309695, batch number#: unknown.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.Email(s) attached.Item: 309695, quantity affected: (b)(4) case, serial/lot number:unknown, po : (b)(4).Are any samples available for return? yes.Reported issue: one bd syringe to be defective, has unusual stain inside of package.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported there was an unusual stain inside of package.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, three photos of a 10ml control syringe from lot 4094832 were received and evaluated by our quality team.One photo shows the top web side of a package with all applicable product information.Two photos show one syringe in a sealed package with a reddish-brown foreign matter on the thumb grip.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 4094832.The review revealed all visual inspections were performed per requirements with no quality notifications related to the defect reported.Lot 4094832 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.

• 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: 19745318
• Report Number: 1213809-2024-00460
• Device Sequence Number: 6532231
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955(11)240403(17)290331(10)4094832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Device Catalogue Number: 309695
• Device Lot Number: 4094832
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown