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	01/03/2025
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 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 chemo secondary tubing was leaking at the insertion site of the secondary tubing to the green cap.Patient noticed this immediately.Tubing was replaced, majority of the chemo in line was expelled back into the bag.Patient was unharmed.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual examination was conducted and no damages or abnormalities were identified.The infusion set was then primed by connecting it to an infusion bag full of water and a smartsite connector connected to the texium connector in order to open the flow path.While priming leakage was noticed coming from in between the texium connector and the smartsite connector.The customer complaint of leakage was verified.A trend for the failure 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 model 1001336t lot number 22099215 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
No additional information.

• 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: 21294698
• Report Number: 9616066-2025-00122
• Device Sequence Number: 9244961
• Product Code: FPA
• UDI-Device Identifier: 10885403198915
• UDI-Public: (01)10885403198915(11)220909(17)250913(10)22099215
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/04/2025

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 Expiration Date: 09/13/2025
• Device Catalogue Number: 10013364T
• Device Lot Number: 22099215
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown