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	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris texium smartsite low sorbing extension set was leaking the following information was received by the initial reporter with the following verbatim verbatim: the tubing with ref #20350et bd low sorbing extension set 0.2 micron low protein binding filter is leaking at the point of connection.It is a trace amount, but it is leaking.We have been attaching the filter tubing to the end of the chemo tubing so it is attached closer to the patient, but i had a patient who had a small wet spot on his shirt during the infusion.I was able to get him cleaned up and wrapped the texium luer with gauze and tape to prevent any more chemo getting onto the patient and we were able to complete the infusion.It happened again today.I attached the filter tubing to the bottom of the secondary line to keep it away from the patient and when i went to check the lines, there was again a small amount of wetness at the connection site.I have attached a photo of the hook up today with an arrow showing where the leaking is happening.I again wrapped the texium luer with gauze and tape and was able to finish the infusion.There was no liquid noted on the floor or actively dripping, but the luer and tubing below it were wet.
Additional Manufacturer Narrative
The customer reported leakage and returned one photo pointing to the texium component on a 20350et set.The photo verifies the location of the failure but does not show a leak and therefore the complaint cannot be verified.The physical sample is unavailable for investigation.Although we could not confirm the reported 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 could not be performed because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• 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: 21639187
• Report Number: 9616066-2025-00572
• Device Sequence Number: 17814299
• Product Code: FPA
• UDI-Device Identifier: 10885403229756
• UDI-Public: (01)10885403229756
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown