MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD ALARIS CLOSED MALE LUER; 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	10/22/2025
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 the bd alaris closed male luer had leakage.The following information was provided by the initial reporter: we¿ve been receiving multiple reports of leakage from the texium tip again.Additional information received from the customer: what was the issue you experienced? leakage from the tip impact or clinical event that occurred to the patient, healthcare provider or user: the patient woke up due to leakage from the tip.Safety impact was not measured.Couldn¿t estimate the amount of leakage.Both safety and efficacy concerns with leakage and less dose administration than intended.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Not able to assess the adverse events or serious harm caused by administering less dose than intended.
Additional Manufacturer Narrative
Three samples model 10012241-0500, lot 25055184 were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were pressurized with air under water at 30 psi.All 3 leaked at the male luer of the texium.The customer complaint was verified.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.

• Brand Name: BD ALARIS CLOSED MALE LUER
• 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23578282
• Report Number: 9616066-2025-03500
• Device Sequence Number: 9505226
• Product Code: FPA
• UDI-Device Identifier: 10885403221705
• UDI-Public: (01)10885403221705(17)280507(10)25055184
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K053049
• 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): 12/15/2025

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: 10012241-0500
• Device Lot Number: 25055184
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown