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

Catalog Number	309695
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and (b)(6) was used.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Examination of the product involved may provide clarification as to the cause for the reported failure.Batch 5016854 is considered in compliance with our product specification requirements.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
It was reported that the bd syringe control 10ml ll barrel / flange was damaged.The following information was provided by the initial reporter: material # 309695.Batch # 5016854.Verbatim: rcc received a complaint via email.I wanted to bring to your attention feedback that we received from regarding bd 10ml control syringe -product #3096-95 & lot #5016854."we have had several control syringes that have broken as medication was being injected during a surgical procedure.The pieces break off and fly across the room, which could lead to contamination issues and/or safety issues if pieces get left in the surgical field." additional information provided: we have had two surgeons on two different occasions that have had issues with the control syringes, more specifically they fell apart as the surgeons were injecting medication.One broke in half with part of it flying off and bouncing off the wall.The surgeons have requested a replacement and no longer want to use this product.It is a potential for patient harm as it could lead to contamination if it bounced back on the sterile field, or pieces could potentially be left inside the patient.I do not have specific dates, nor do we have any physical samples as the parts were covered in blood.

• 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: 22413396
• Report Number: 1213809-2025-00457
• Device Sequence Number: 8277190
• Product Code: FMF
• UDI-Device Identifier: 00382903096954
• UDI-Public: (01)00382903096954(17)291231(10)5016854
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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: 309695
• Device Lot Number: 5016854
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown