MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS TEXIUM SMARTSITE LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20350ET
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
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 the following information was received by the initial reporter with the following.I have representative samples, in package, not the ones involved with the patient.I met with xxxx and her staff-- while being on site and looking at texium, how things occurred with recent pir's (2 weeks ago) the nurse noticed her gloved being wet--looked like the med (not hazardous) was "seeping" where the texium connection (binded to the 203050et filter set ) to the 2000e smartsite---stand alone smart site attached to a female luer of a port access needle.6-7 infusions occurring on other patients some with multiple texium in use.
Additional Manufacturer Narrative
The customer reported the texium connection was leaking was connected to another set, and returned an unopened, representative sample of material 20350et, lot 24079037.Upon initial visual examination, the set had no defects or abnormalities.The set was tested at 30 psi for ten minutes, but no leak was observed.The complaint was not verified, but the root cause is related to an issue with texium.A device history record review was performed.There was a quality notification issued for the failure mode, associated with the same issue as explained below with the texium.Although we could not confirm the reported failure, a trend has been identified and actions have been initiated to investigate the texium leakage 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.

• Brand Name: BD ALARIS TEXIUM SMARTSITE LOW SORBING EXTENSION SET
• 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: 21862419
• Report Number: 9616066-2025-00950
• Device Sequence Number: 18103277
• Product Code: FPA
• UDI-Device Identifier: 10885403229756
• UDI-Public: (01)10885403229756(11)240702(17)270702(10)24079037
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 05/27/2025

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: 20350ET
• Device Lot Number: 24079037
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown