MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. EXT 8; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ5313
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
I was told to slowly remove the syringe from the max zero to prevent back flow or spray back.I remove the syringe slowly after drawing blood from the picc and the max zero sprayed blood into the air toward my face.
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
H10: the customer reported the maxzero sprayed blood, and returned one photo and label of material mz5313, lot 25095264.The photo verified the complaint of tubing separation from the y site.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 potential root cause for the issue is related to the solvent application onto the tubing.The manufacturing site addressed the failure on jan.20th, 2026, after the batch was released.The standard work instruction was updated to assist with better cleaning and functioning of the solvent dispenser before production.
Event or Problem Description
No additional information was provided.

• Brand Name: EXT 8
• 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24218313
• Report Number: 9616066-2026-00177
• Device Sequence Number: 8579257
• Product Code: FPA
• UDI-Device Identifier: 10885403471261
• UDI-Public: (01)10885403471261(17)280904(10)25095264
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 04/06/2026

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: MZ5313
• Device Lot Number: 25095264
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown