MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. De C.V. BD smartsite extension set; Intravascular administration set

Catalog Number	20027E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd smartsite extension set was leaking.The following information was received by the initial reporter with the following verbatim.It was reported by customer that while preparing a csp and priming the line with drug the tubing was found to be leaking out of the 0.2-micron filter.The leaking tubing was identified prior to interaction with a patient.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of leakage from the fitler could not be verified due to the product not being returned for failure investigation.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.The root cause of this failure could not be identified without a sample investigation.The root cause in filter cases can be related to the medication used with the filter, causing the filter to wet-out of the air vents.

• Brand Name: BD smartsite 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 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. De C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50889056
• Report Number: 9616066-2026-02419
• Device Sequence Number: 9791546
• Product Code: FPA
• UDI-Device Identifier: 10885403234859
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 20027E
• Device Lot Number: 25125180
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown