MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB; PISTON SYRINGE

Catalog Number	309580
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and il was used.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 syringe 3ml ll w/ndl 18x1-1/2 rb had visible silicone.The following information was provided by the initial reporter: material # 309580 , batch # 1242791.It was reported by customer that thick liquid inside syringe.Rcc received a complaint via email.Contact name: xxx, contact number: xxx, contact email (if available): xxx, item(s): 309580, lot(s): 1242791, date incident occurred: (b)(6)2025.Was the patient impacted? were not able to use if yes, describe: thick liquid inside syringe is a sample available? has video.Customer response on (b)(6) 2025.Not a problem! attached please find the video of the syringe in question.This video was taken after drawing air only into the syringe (the syringe had not entered any medication and was fresh out of the packaging).I have several other syringes from this same lot and have not experienced this issue yet in any other syringe.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Pr (b)(6), supplemental mdr, silicone visible.A video of a 3 ml luer-lok syringe was received and evaluated.The video shows a single syringe with the plunger rod being retracted, during which silicone stringing is observed between the stopper and the top of the barrel.The condition observed is non-conforming per product specification.Potential root cause for the silicone excessive defect is associated with the assembly process.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 units.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Furthermore, a device history record review was completed for provided lot number 1242791.A review showed no rejected inspections or quality issues during the production 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.

• Brand Name: BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB
• 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: 21849369
• Report Number: 1213809-2025-00279
• Device Sequence Number: 8642217
• Product Code: FMF
• UDI-Device Identifier: 30382903095804
• UDI-Public: (01)30382903095804(11)210830(17)260831(10)1242791
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: Lay User/Patient
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 309580
• Device Lot Number: 1242791
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown