MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD TEXIUM SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	70001B-07T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd texium secondary set smartsite needle-free valve bag access port had leakage.The following information was provided by the initial reporter: many reports received in regards to bd low sorbing secondary set smartsite needle-free valve bag access port ref # 70001b-07t.5 reports total reported in terms of leaking.One report involved starting a piggyback infusion of fluorouracil 900mg, a leak occurred at the connector site to the primary iv line.Approximately 5 ml of fluid leaked, but none came into contact with the patient.The leak was contained with a disposable pad.Pharmacy was notified.Similar events could occur at other facilities using the same bd low sorbing secondary set smartsite needle-free valve bag access port if there are product defects, compatibility issues, or assembly errors.If leakage occurs with hazardous drugs like chemotherapy, staff could be exposed to cytotoxic fluids, presenting health risks such as skin irritation or long-term effects.Additionally, medication loss could lead to underdosing, impacting patient care.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Negative outcome included major leaks with the products with no patient harm.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD TEXIUM SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT
• 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25337618
• Report Number: 9616066-2026-01413
• Device Sequence Number: 10002880
• Product Code: FPA
• UDI-Device Identifier: 10885403240997
• UDI-Public: (01)10885403240997(11)241002(17)271002(10)24109018
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 70001B-07T
• Device Lot Number: 24109018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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