MAUDE Adverse Event Report: BECTON DICKINSON TEXIUM NEEDLE-FREE SYRINGE 30ML; SYRINGE, PISTON

Catalog Number	MY8030
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: my8030; batch#: 24066951.It was reported by the customer that customer's concern is high since this continues to happen.Customer's concern is high since this continues to happen additional information: please provide the address of the facility for us to ship the return label? could you please provide a further description of the exact issue? one of our 30 cc texium syringes was leaking when the technician was using not connected to a smart-site needle free valve.The chemotherapy was leaking from the texium tip, not the bonded piece above it.Makes me question if the internal leur lock mechanism was slightly off.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No adverse events occurred with the technician.He did have to change his gloves after the leak, but no personal harm.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
1.Please provide the address of the facility for us to ship the return label? xxxxxx.2.Could you please provide a further description of the exact issue? one of our 30 cc texium syringes was leaking when the technician was using not connected to a smart-site needle free valve.The chemotherapy was leaking from the texium tip, not the bonded piece above it.Makes me question if the internal leur lock mechanism was slightly off.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No adverse events occurred with the technician.He did have to change his gloves after the leak, but no personal harm.
Additional Manufacturer Narrative
One sample of my8030 was submitted for quality evaluation.Visual inspection of the sample was conducted an there was no visible damages or abnormalities.A smartsite connector was then connected to the texium connector to fill the syringe with water.The syringe was then emptied slowly and a leak was identified between the union between the texium connector outlet and the smartsite inlet port.The customer complaint of leakage was confirmed.A trend has been identified and actions have been initiated to investigate the issue.Corrective actions taken during this investigation will be implemented in our production process to further increase the robustness and reliability of the device and prevent future occurrences of this type.A device history record review for model my8030 lot number 24066951 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE 30ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20855224
• Report Number: 9616066-2024-01881
• Device Sequence Number: 21004623
• Product Code: FMF
• UDI-Device Identifier: 10885403230523
• UDI-Public: (01)10885403230523(11)240625(17)270625(10)24066951
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K231888
• 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): 02/20/2025

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: MY8030
• Device Lot Number: 24066951
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown