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

Catalog Number	10014881
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
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
It was reported that the bd alaris smartsite low sorbing secondary set had separated.The following information was provided by the initial reporter: the bd alaris pump infusion set's tubing may separate, leak, or fail to prime.When this occurs: treatment will be delayed.There is potential for patient blood loss.The compromised administration set presents a route for infectious agents.Medication may spill, potentially exposing staff and patients to toxic medication (e.G., chemotherapy agents).Also, the spill may present a fall risk.Medication may be wasted.

• Brand Name: BD ALARIS SMARTSITE LOW SORBING SECONDARY SET
• 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: 25449448
• Report Number: 9616066-2026-01520
• Device Sequence Number: 12222392
• Product Code: FPA
• UDI-Device Identifier: 10885403221934
• UDI-Public: (01)10885403221934
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: 10014881
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/24/2026
• 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