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

Catalog Number	10012241-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
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 texium closed male luer cap was leaking.The following information was received by the initial reporter with the following verbatim it was reported by customer that this was a stand alone texium or was this a bonded set.
Additional Manufacturer Narrative
One photo was taken by the customer that is unable to verify the complaint.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 a lot number was not provided by the customer.

• Brand Name: BD TEXIUM CLOSED MALE LUER CAP
• 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: 23349138
• Report Number: 9616066-2025-03217
• Device Sequence Number: 12705397
• Product Code: FPA
• UDI-Device Identifier: 10885403221705
• UDI-Public: (01)10885403221705
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: UNKNOWN
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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