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

Catalog Number	309605
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
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 bd syringe 10ml ll tip bulk convenience pak contained foreign matter.Complaint via email.During visual inspection of lot 20260330-5298a2, phenylephrine hci 1000 mcg in 10 ml of ns syringe, one syringe was found to have an ink spot on the plunger lid, one was found to have a defective plunger seal and one had defective syringe markings with the numbers faded off completely.These units are available for return.Details for your investigation: product: sterile syringe tray 10ml lot number: 5310147 part number: 309605 number of defective units: 3 defect type: ink spot, syringe defect & defective syringe markings product complaint: (b)(4).Can you please provide an exact date of event in format dd-mmm-yyyy? 30-mar-2026 describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.N/a ¿ no patient usage at this point.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.Three samples and three photos of 10 ml luer lok syringes were received and evaluated.All samples were received loose, one sample showed no defects, one exhibited a stopper jammed between the barrel and plunger rod, and one had grossly skewed scale markings resulting in missing print.The photos show a loose syringe with an unknown red cap attached, including one image showing a black spot on the cap, however, this cap is not associated with the canaan manufacturing plant, as it is neither manufactured nor supplied with the product.The remaining images support the observed scale marking and stopper jam issues.The observed conditions are nonconforming to product specifications.The potential root cause for the scale marking defect is associated with the marking process, while the stopper jam defect is likely related to the assembly process.A device history record review was completed for material number 309605, lot 5310147.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and is in compliance with applicable product specifications.

• 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: 24943397
• Report Number: 1213809-2026-00212
• Device Sequence Number: 17548733
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/28/2026

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: 309605
• Device Lot Number: 5310147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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