MAUDE Adverse Event Report: Sistemas Medicos Alaris S.A de C.V. Maxzero; Set, Administration, Intravascular

Catalog Number	MZ5303
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, maxzero, occlusion, during use.The following was provided by the initial reporter: after connecting the b.Braun discofix to an mz5303, the anesthesiologist was unable to inject anything.He showed me the issue, and we tried several times¿including attempting to screw the set on more tightly.He noted that this was already the second time it had happened and pointed out the danger involved: if there were an urgent need to administer a rapid injection during surgery, the iv line would fail to work.This is not the first complaint in belgium regarding iv connections and our max zero portfolio.Additional information: was there any patient impact? the max zero was attached to a patient's catheter, and the b.Braun set was connected to it; consequently, the medication was not flowing into the catheter.Please confirm how the fault was identified? the max zero was attached to a patient's catheter, and the b.Braun set was connected to it; consequently, the medication was not flowing into the catheter.Please confirm the make and model of the connecting product(s) to the maxzero extension? see attachment; i had already uploaded this photo to the pir.Please confirm the exact location of the reported fault within the set? the fluid from the b.Braun set did not flow through after connection to the max zero; however, when we attached a syringe to the max zero, we were able to flush it without any issues.Please confirm what substance was being infused during the time of the event? nacl infusion.
Additional Manufacturer Narrative
B3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: Maxzero
• 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 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50854443
• Report Number: 9616066-2026-02401
• Device Sequence Number: 9497725
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: MZ5303
• Device Lot Number: 26045341
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown