MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 21X1-1/2 RB; PISTON SYRINGE

Catalog Number	309577
Medical Device Problem Codes	Contamination (1120); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2025
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 syringe 3ml ll w/ndl 21x1-1/2 rb had foreign matter.The following information was provided by the initial reporter: material#: 309577.Batch#: 5204814.Verbatim: rcc received a complaint via call.Email(s) attached.Customer states that the 3ml x 21g 1 1/2 syringe needle combo contains a clear sticky looking liquid with in the syringe barrel.Caller states that the whole box does not look the same.Caller states only a few of the syringes have contiend the clear substance.Product code 309577, lot#5204814.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Based on the description, the foreign material or ¿sticky-looking liquid¿ observed in the syringe may be silicone, an inert, non-toxic medical-grade lubricant used in disposable hypodermic products.Silicone is an integral component of the syringe design, enabling proper functionality without impacting safety or efficacy.This material has been used in this application for over 25 years, with an estimated distribution exceeding 30 billion units, and there are no known reports of adverse clinical effects associated with unintentional delivery of silicone fluid lubricant.Furthermore, a device history record review was completed for provided lot number 5204814.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 21X1-1/2 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: 23272172
• Report Number: 1213809-2025-00641
• Device Sequence Number: 9574838
• Product Code: FMF
• UDI-Device Identifier: 30382903095774
• UDI-Public: (01)30382903095774(17)300630(10)5204814
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/08/2025

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 Catalogue Number: 309577
• Device Lot Number: 5204814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/08/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown