MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 23X1-1/2 RB TW; PISTON SYRINGE

Model Number	309589
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	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used investigation summary: one 3ml syringe with needle (p/n 309589) was received in a partially open blisterpak from batch #0308898.The syringe was visually evaluated.No visible defects were observed on the syringe.The "droplets" of liquid inside the syringe appeared to be silicone and the normal amount expected was observed.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.Since root cause could not be defined, corrective actions are not necessary at this time.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.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
It was reported that the syringe 3ml ll w/ndl 23x1-1/2 rb tw experienced liquid/moisture/droplets in syringe.The following information was provided by the initial reporter: material no: 309589, batch no: 0308898.The syringe has a liquid inside the syringe, they arrived this way.Upon opening it only some of the syringes have a droplet inside of some sort of lubricate.

• Brand Name: SYRINGE 3ML LL W/NDL 23X1-1/2 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12040515
• Report Number: 1213809-2021-00438
• Device Sequence Number: 11762282
• Product Code: FMF
• UDI-Device Identifier: 30382903095897
• UDI-Public: 30382903095897
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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 Expiration Date: 10/31/2025
• Device Model Number: 309589
• Device Catalogue Number: 309589
• Device Lot Number: 0308898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1