MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. ALARIS SMARTSITE; 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	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unspecified bd infusion set had leakage.The following information was provided by the initial reporter: i also had another issue that was reported at the same time as the original complaint related to a leaking filter (no packaging).
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.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information: b.3.Date of event has since been provided.D.4.Brand name, catalog #, udi.G.510(k).Investigation summary: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.No product will be returned per customer.No investigation was performed.

• Brand Name: ALARIS SMARTSITE
• 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: 24757178
• Report Number: 9616066-2026-00855
• Device Sequence Number: 21107462
• Product Code: FPA
• UDI-Device Identifier: 10885403234859
• UDI-Public: (01)10885403234859
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: UNKNOWN
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown