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	12/01/2023
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
It was reported that the bd luer-lok syringe contained foreign matter.The following information was provided by the initial reporter: "it was reported by the customer that syringe contains a small white object lodged in the hub/barrel region of syringe.Compounding halted and remaining batch discarded when syringe containing foreign object was attached to.Pin dispenser and plunger was pulled back.".
Additional Manufacturer Narrative
(b)(4) ¿ follow up mdr for device evaluation: one sample of a 1 ml luer-lok syringe was received by bd.A quality engineer was able to review the sample from lot number 3117449 regarding material number 309659.The sample received loose had dried silicone particles larger than level 4 inside the barrel.Ftir analysis was performed and verified the foreign matter particulate to silicone used in the manufacturing process.The condition observed is non-conforming per product specification.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.Silicone has been in use in this application for over 20 years, with estimated distribution well in excess of 25 billion units.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Silicone is applied as a spray of particles to the inside of the barrel.It is unclear what type of storage and handling conditions the product was subjected to after leaving the manufacturing plant.It is possible certain conditions outside the manufacturing environment contributed to the condition of silicone particles observed in the sample received.The condition observed could not be confirmed to have originated at the manufacturing plant, therefore corrective actions are not necessary.A device history record review was completed for provided lot number 3117449 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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.

• 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: 18354515
• Report Number: 1213809-2023-01472
• Device Sequence Number: 6923847
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 03/04/2024

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: 309659
• Device Lot Number: 3117449
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown