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

Catalog Number	309575
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll w/ndl 21x1 rb had foreign matter.The following information was provided by the initial reporter; material #309575 lot #4354918 verbatim: rcc received a complaint via email.Email(s) attached.Last month we received product code 309575, lot number 435918 of 3cc syringes.At the beginning of the month of july, we started using the lot number in production and some of our technicians have noticed there is something stuck to the needles of a significant amount of the syringes.The technicians have been asked to remove these syringes from production when they notice something stuck to the needle as we cannot afford to have particulate on a needle and injected into a patient.This issue was noticed during the first week of (b)(6).Additional information provided; 1.If possible, could you please confirm the exact date of the event in the format dd-mmm-yyyy? 24 jul 2025 2.Lot number [435918] was not match with material number [ 309575 - syringe 3ml ll w/ndl 21x1 rb].Could you please check and reconfirm the lot number? the lot number is 4354918 3.Could you please reconfirm whether the sample is available for our investigation? yes, the syringes are available to send back.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter a report was received indicating that a foreign substance was adhered to the needle.To support the investigation, five unpackaged samples and one photograph were submitted for evaluation by the quality team.A visual inspection was conducted, revealing that each needle exhibited a localized droplet of silicone lubricant applied in a thin layer.The photograph provided depicts several of the submitted samples.No additional defects or irregularities were observed.This condition may occur due to a mechanical jam during the lubricant application process.A review of the device history record for material number 309575, lot 4354918, was completed.All visual inspections were performed in accordance with established requirements, and no quality notifications related to the reported condition were identified.The lot was inspected per the inspection control plan and approved for shipment.Additional device history records were reviewed for each batch of needles used in the manufacturing of this lot.No documentation of similar defects was found throughout the production runs of these batches.Based on the investigation and analysis of the returned samples, the condition reported by the customer has been confirmed.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 was provided.

• Brand Name: BD SYRINGE 3ML LL W/NDL 21X1 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: 22800379
• Report Number: 1213809-2025-00536
• Device Sequence Number: 12902535
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/08/2025

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: Health Professional
• Device Catalogue Number: 309575
• Device Lot Number: 4354918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown