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

Catalog Number	2452-0007
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
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 bd alaris smartsite pump infusion set was discolored the following information was received by the initial reporter with the following.It was reported by customer that drip chamber is brown / plastic appears distorted.Usually clear.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
Two samples were returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Sample had a normal brownish tint that is to be expected sometimes during the gamma sterilization.The customer complaint that the set was discolored is not an issue.The root cause of this discoloration is related to the sterilization procedure which iv sets undergo to help ensure product sterility.These iv sets are sterilized by irradiation, which uses electron beam or gamma rays to produce a sterile and safe iv product per iso 11137-1 and iso 11137-2, international standards for the sterilization of health care products.These standards are recognized consensus standards by the fda, which are adhered to by bd to specify the requirements for the development, validation, and routine control of a radiation sterilization process.The irradiation process is known to modify polymers which causes some discoloring, depending on the applied radiation level (dose) and material choices.The degree or intensity of discoloration can also change over time, as it approaches shelf life, and under certain storage conditions such as high temperatures.Nonetheless, this type of discoloration is strictly cosmetic and does not affect the safety and functionality of the device as tested and sterilized.A device history record review 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: ALARIS SMARTSITE
• 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: 22137718
• Report Number: 9616066-2025-01469
• Device Sequence Number: 20867961
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: (01)10885403219870(11)220617(10)22066054
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 2452-0007
• Device Lot Number: 22066054
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown