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

Catalog Number	11532269
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported, alaris smartsite, tip of the plastic spike broke off in the opening of the iv bag after spiking it causing the medication having to be thrown away.
Additional Manufacturer Narrative
Investigation results: the customer reported the tip of the plastic spike broke off, and returned one photo of material: 11532269, lot: 25125022.Visual examination confirmed the customer report of component damage on the spike.There is no physical sample available for investigation.The information was forwarded to the supplier of the spike for further investigation.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.The supplier of the spike component conducted an additional investigation.They found their process held up the quality and no other similar reports or findings on the released lot number.No actions were able to be taken as their was not confirmed root cause.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• Brand Name: ALARIS SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24911040
• Report Number: 9616066-2026-01005
• Device Sequence Number: 18413457
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: (01)10885403232343(17)281130(10)25125022
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: Health Professional
• Device Catalogue Number: 11532269
• Device Lot Number: 25125022
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown