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

Catalog Number	MZ1000 CHINA
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Imdrf annex f code changed from f26 to f2301.Investigation result: description of event.It was reported that, upon connecting the infusion connector to the flush connector, residue was discovered within the connector.Investigation results.A complaint sample mz1000 china was not available for investigation.The customer confirmed that the complaint sample was associated with lot 25085184; however, no additional information was available to support the investigation.The details of the reported event were forwarded to the manufacturing site for investigation.A review of the production records for lot 25095184 did not identify any in-process testing failures or quality deviations that may have caused or contributed to a report of this nature.The root cause of the reported event could not be determined because no sample was received for evaluation.Without a sample for examination, it was not possible to determine whether a manufacturing-related issue could have caused or contributed to the reported event.A review of available complaint history for the relevant batch and associated defect code was conducted as part of the investigation.The information reviewed did not change the conclusions reached during the investigation.Complaint data continues to be monitored through established quality system processes, as appropriate.What does this mean for me? based on the information available, the reported event could not be conclusively linked to a specific failure mode because no sample was available for evaluation.The investigation summary indicates that this is a rare occurrence with a small number of similar reports against the product mz1000 china in the past 12 months.

• 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50670401
• Report Number: 9616066-2026-02243
• Device Sequence Number: 10098955
• Product Code: FPA
• UDI-Device Identifier: 10885403224782
• UDI-Public: (01)10885403224782(10)25085184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: MZ1000 CHINA
• Device Lot Number: 25085184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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