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

Catalog Number	22003E-07
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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 extension set had connection issues the following information was received by the initial reporter with the following: it was reported by customer that when they are attaching our tubing for our pet scans, we are meeting resistance immediately at the smartsite needle-free connector.It also occasionally occurs while we are priming the extension set before attaching to the patient.
Additional Manufacturer Narrative
The customer reported that the sets are giving resistance to the flush, and returned 3 samples, two of reported lot 25029390, 1 of returned lot 25075720.All three samples are of material 22003e-07.The two samples of lot 25029390 were able to flush, did not show smart site issues, and could not verify the complaint.The third sample of lot 25075720 was able to verify, and was occluded at the smart site.After initial resistance, the occlusion was broken, and flow was achieved with no continuing issue.A device history record review was performed.There were no quality notifications issued for the failure mode for either lot number reported by the customer during the production build of this set.The manufacturing plant found the root cause for the occlusion to be related to incorrect fluorosilicon (lubricant) application.The lubricant within the smart site piston helps it to open up without difficulty.The plant addressed the failure by checking the fluorosilicon dispenser, adjusting the hoses, and replacing a broken cable on the dispenser.

• Brand Name: BD ALARIS SMARTSITE EXTENSION 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: 23688978
• Report Number: 9616066-2025-03599
• Device Sequence Number: 9153090
• Product Code: FPA
• UDI-Device Identifier: 10885403242045
• UDI-Public: (01)10885403242045(17)260730(10)25075720
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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 Expiration Date: 07/30/2026
• Device Catalogue Number: 22003E-07
• Device Lot Number: 25075720
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown