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

Catalog Number	11171447
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite pump infusion set was occluded.The following information was received by the initial reporter with the following verbatim it was reported by customer that they unable to inject medication through port.
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
The customer reported they are unable to achieve flow in the port, and returned one used sample of material 11171447, lot unknown.Upon initial visual examination, the set had no defects or abnormalities.The smart site nearest the patient was tested with a cut-off syringe, in order to visualize the smart site blue piston, when actively engaged.The piston did not have an opening when engaged, and the complaint of occlusion was verified.A device history record review could not be performed on material 11171447 because the lot number is unknown.The manufacturing plant could not find the root cause for the occlusion in smart site issue.The plant was able to attribute the possible root cause to an incorrect application of fluorosilicon (lubricant) into the smart site.The fluorosilicon dispenser station went under maintenance on march 4th, 2025.It is not possible to know if the action was before or after the sample was released, without the lot number.

• Brand Name: BD ALARIS SMARTSITE PUMP INFUSION 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23619317
• Report Number: 9616066-2025-03531
• Device Sequence Number: 21343402
• Product Code: FPA
• UDI-Device Identifier: 07613203021234
• UDI-Public: (01)07613203021234
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: 11171447
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown