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

Catalog Number	10013902
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite extension set was occluded.The following information was provided by the initial reporter: the filter on the tubing wasn't working and fluid was not able to pass through it.Additional information received from the customer: describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient harm resulted from this event.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Additional information: (h) attached medwatch.Investigation results: 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.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE EXTENSION 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: 23565847
• Report Number: 9616066-2025-03495
• Device Sequence Number: 10173024
• Product Code: FPA
• UDI-Device Identifier: 10885403233814
• UDI-Public: (01)10885403233814(17)280605(10)25065161
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 11/27/2025

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: 10013902
• Device Lot Number: 25065161
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/16/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown