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

Catalog Number	2423-0007
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 pump infusion set had foreign matter in the fluid path.The following information was provided by the initial reporter: we have a complaint from our customer on item 2423-0007/lot# (10)25095499 due to dirty iv tubing.Additional information received from the customer: when was this defect observed? during or before use? the tubing was brought to my attention on 12/11/2025.I was found when opening the tubing before use.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No event reported.
Additional Manufacturer Narrative
One sample and five photos were received for quality evaluation.Inspection of the sample and photos indicate a brownish substance is located at the top of the drip chamber.The customer complaint of foreign matter was confirmed.The investigation was forwarded to the supplier for root cause investigation.It was determined that the reported "dirt" was actually embedded degraded pvc that can happen during the drip chamber molding process.The supplier has implemented different actions to address the issue.Additionally, a review of the possible production lots of the sample was conducted.There was no indication of embedded pvc on any of the production samples.The issue will continue to be monitored and tracked in order to determine if further actions are needed.A device history record review for model 2423-0007 lot number 25095499 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24033034
• Report Number: 9616066-2025-04145
• Device Sequence Number: 9141288
• Product Code: FPA
• UDI-Device Identifier: 07613203020985
• UDI-Public: (01)07613203020985(17)280914(10)25095499
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 2423-0007
• Device Lot Number: 25095499
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown