MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD TEXIUM NEEDLE-FREE SYRINGE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MY8020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
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 texium needle-free syringe was leaking the following information was received by the initial reporter with the following verbatim it was reported by the customer that ¿while administering 5fu push via ffiv, the texium syringe started to leak at the y-site where the texium clave is attached to the bd tubing smart site.Administration stopped; all chemo spilled approx.(0.25mls) was absorbed on chux pad.Syringe removed with a drop of 5fu on end on texium clave (4mls left in syringe).Pharmacist in ep2 came to chairside to assess.Leaking syringe was bagged in chemo bag and sent back to pharmacy per pharmacy request.New syringe made with 4mls of 5fu and administered with new tubing ffiv without incident.¿.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
It was reported by the customer that ¿while administering 5fu push via ffiv, the texium syringe started to leak at the y-site where the texium clave is attached to the bd tubing smart site.One sample of my8020 was submitted for quality investigation.Visual inspection was conducted, and no damages or abnormalities were identified.A sample bd smartsite was connected to the texium connector in order to fill the syringe with water.The water was then pushed out of the syringe to determine if there is leakage between the texium connector and the smartsite.Leakage was noticed between the texium connector and smartsite.The customer complaint of leakage was verified.The investigation was forwarded to manufacturing for further evaluation and determination of the root cause of the failure.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 my8020 lot number 24075163 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: BD TEXIUM NEEDLE-FREE SYRINGE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• 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: 21068785
• Report Number: 9616066-2024-02170
• Device Sequence Number: 12855308
• Product Code: FPA
• UDI-Device Identifier: 10885403221682
• UDI-Public: (01)10885403221682(11)240726(17)270726(10)24075163
• 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): 03/24/2025

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: Other
• Device Catalogue Number: MY8020
• Device Lot Number: 24075163
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown