MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. 13 MM SS VIAL ACCESS DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2203E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported flow issues, occlusion.Verbatim: complaint for pressure irregularity that need additional testing.Customer reports no damage to vial adaptor or syringe and everything was reported to have been attached correctly.The customer reports when connected the plunger would not press down.When disconnected from vial adaptor the plunger worked fine.
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.
Additional Manufacturer Narrative
The customer reported that the vial adapter would not infuse, and returned one sample of material 2203e, lot 24095150.Upon initial visual examination, the set had no defects or abnormalities.The set was infused with water from a 10 ml bd syringe, and no issues were observed.The complaint of occlusion in the vial adapter could not be replicated.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 root cause of this issue is being addressed under a funded project at the plant level, with three root causes being identified.The plant is working to address all three.Opportunities on fluorosilicon application method.Limitations of joint use between glass syringe and vial adapter.Opportunity in validated sterilization range.

• Brand Name: 13 MM SS VIAL ACCESS DEVICE
• 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: 24292014
• Report Number: 9616066-2026-00254
• Device Sequence Number: 10382221
• Product Code: FPA
• UDI-Device Identifier: 07613203011792
• UDI-Public: (01)07613203011792(11)240913(17)270913(10)24095150
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K233021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 2203E
• Device Lot Number: 24095150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown