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

Catalog Number	20350ET
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris texium smartsite low sorbing extension set was leaking.The following information was received by the initial reporter with the following verbatim.It was reported by customer that texium bonded set leaked upon either connection or disconnection to smartsite.Drug leaked.
Additional Manufacturer Narrative
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.A device history record review for material# 20350et and lot# 24079037 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2024.There were quality notifications issued for the failure mode reported by the customer during the production build of this set for lot 24079037 as notification id# (b)(4) on (b)(6) 2025.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD ALARIS TEXIUM SMARTSITE LOW SORBING EXTENSION 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: 21963391
• Report Number: 9616066-2025-01123
• Device Sequence Number: 7104801
• Product Code: FPA
• UDI-Device Identifier: 10885403229756
• UDI-Public: (01)10885403229756(11)240702(17)270702(10)24079037
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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
• Report Date (Section B): 04/15/2025

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: 20350ET
• Device Lot Number: 24079037
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/05/2025
• 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