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

Catalog Number	309580
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one 3ml syringe with needle attached was received in an opened package from batch #8257999 (p/n 309580).The sample was visually evaluated.The syringe was observed to have silicone pooling on top of the stopper surface.The silicone was also stringing from the bottom of the barrel.The amount of silicone observed was excessive per product specification.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Please note that 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.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the sample provided.Root cause description: potential root cause for the excess silicone presence defect is associated with the assembly process.Rationale: no corrective actions are necessary based on the defective rate identified.Batch 8257999 is considered in compliance with our product specification requirements.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.
Event or Problem Description
It was reported that a clear, sticky foreign matter was noticed inside the bd luer-lok¿ syringe with attached needle before being used.The following information was provided by the initial reporter: "health professional at clinic was about to administer medication when noticed a clear, sticky glue-like liquid inside of the syringe.".

• Brand Name: BD LUER-LOK SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8730843
• Report Number: 1213809-2019-00649
• Device Sequence Number: 2573204
• Product Code: FMF
• UDI-Device Identifier: 30382903095804
• UDI-Public: 30382903095804
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 309580
• Device Lot Number: 8257999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other