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

Catalog Number	309575
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl 21x1 rb demonstrated connection issues.Verbatim: rcc received a complaint via email: i am writing to bring to your attention an issue with the 3 ml syringes we received for the lot number mentioned in the attached form.We have identified number of defective 3 ml syringes within the cases received.Specifically, the syringe plunger seal is not properly intact on several units found in the boxes.Additionally, some of the syringes we found with loose needles in the pack.For your reference and further review, i have attached photos showing examples of the defective syringes.
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 - syringe needle connectivity issue.Sixteen samples and one photograph of 3 ml luer lok syringes with 21 × 1" needles (part number 309575) were evaluated.Two sealed syringes were received from batches 5083505 and 5241754; one had a stopper insecurely attached to the plunger rod, and the other showed damage to the plunger rod and barrel tip, resulting in a partially attached needle.Among the fourteen loose syringes, ten arrived without needles, eight with no defects and two with barrel damage, while four arrived with needles attached, including one acceptable sample and three with stoppers insecurely attached.In addition, eight loose needles were received.The photograph provided aligns with the observed defects.These conditions do not meet product specifications.Although hub removal force testing at the time of manufacture met requirements, post manufacturing conditions are unknown; therefore, users should ensure proper needle connection by hand tightening before use.The damaged barrels, plunger rods, and insecure stoppers are potentially linked to the assembly process.A device history record review was completed for material number 309575, lots 5083505 and 5241754.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.Both lots met acceptance criteria per the inspection control plan, were approved for shipment, and are in compliance with applicable product specifications.Complaints received for this device and the reported condition will continue to be tracked and trended.This information will be included in trend reports and monitored on a monthly basis.Our business team regularly reviews the collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD LUER-LOK
• 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: 24063085
• Report Number: 1213809-2026-00005
• Device Sequence Number: 10385609
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750(17)300731(10)5241754
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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 Catalogue Number: 309575
• Device Lot Number: 5241754
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown