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

Catalog Number	10013364T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 alaris smartsite texium secondary set was leaking.The following information was received by the initial reporter with the following verbatim it was reported by customer that the green cap that is bonded to end of secondary set began leaking as a chemotherapy mix was finishing up.
Additional Manufacturer Narrative
Investigation summary: it was reported that the green cap that is bonded to end of secondary set began leaking.One sample model 10013364t, lot 24109021 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and then pressurized at 30 psi for 10 minutes.No leak was observed.The customer complaint was unable to be replicated.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 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Samples received.

• Brand Name: BD ALARIS SMARTSITE TEXIUM SECONDARY 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: 21529968
• Report Number: 9616066-2025-00426
• Device Sequence Number: 9584500
• Product Code: FPA
• UDI-Device Identifier: 10885403198915
• UDI-Public: (01)10885403198915(11)241002(17)271002(10)24109021
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/24/2025

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: 10013364T
• Device Lot Number: 24109021
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown