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

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	09/23/2024
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 # 4122242.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.Just want to bring this to your awareness, below are pics of sin# 362157 sterile control syringe 10ml.When the or team opened it, it was dirty.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Foreign matter.One sample and three photos were provided to our quality team for investigation.Through visual inspection, it was observed that the sample has a brownish discoloration present on the thumb grip.Fourier transform infrared spectroscopy (ftir) analysis was performed, and the most likely match found is grease used in the manufacturing process.The condition observed is non-conforming per product specification.Potential root cause for the foreign matter non-fluid path internal to package defect is associated with the molding process.As corrective action, quality alert will be issued to the plant.Furthermore, a device history record review was completed for provided lot number 4122242.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD LUER-LOK
• Common Device Name: SYRINGE, PISTON
• 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: 20445541
• Report Number: 1213809-2024-00709
• Device Sequence Number: 15460298
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955(11)240501(17)290430(10)4122242
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/05/2024

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: 4122242
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown