MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10012241-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure 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 for material # 10012241-0500 and lot# 25025321 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12feb2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.
Event or Problem Description
It was reported that the bd texium closed male luer with female cap had leakage.The following information was provided by the initial reporter: we recently had an inpatient leak involving texium.A nurse disconnected between the texium and the smartsite, and a chemotherapy spill occurred.We are also trying to understand whether this may be related to the max zero needleless connectors, since they are designed to push fluid out and we typically expect to see fluid present at the endo f the connector when it's not part of a closed system.Additional information received from the customer: kindly provide the material number and batch/lot number of the max zero needleless connectors.I'll inquire.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.Can you please provide an exact date of event in format dd-mmm-yyyy? 23-april-2026.

• Brand Name: BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25153514
• Report Number: 9616066-2026-01271
• Device Sequence Number: 18827627
• Product Code: FPA
• UDI-Device Identifier: 10885403221705
• UDI-Public: (01)10885403221705(17)280212(10)25025321
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K053049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 10012241-0500
• Device Lot Number: 25025321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown