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

Catalog Number	MZ1000 CHINA
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation result: one mz1000 china sample was received without any packaging for investigation; no connecting product was available to support the investigation.The customer reported that the affected sample was from lot 25085184 and that "during use, the stopper did not spring back; there was one defective unit." as part of the investigation, the customer provided a photograph of the affected sample; analysis of which confirmed that the piston was recessed within the housing of the maxzero.The returned sample was subjected to functional testing by priming and flushing using a 50ml bd plastipak syringe; the sample was successfully accessed and flushed.No recessed pistons were observed during disconnection with the connecting luer following several access attempts.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 25085184 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance a definitive cause for the customer's experience could not be determined; however it is possible that medication residue within the housing may have contributed to the customer's experience, as it may have impeded the free-movement of the maxzero piston.As stated in the directions for use "flush the maxzero after each use with normal saline or in accordance with facility protocol." although it was not possible to determine a definitive cause for the customer's experience, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that complaints of this nature are rare against the maxzero product family, with no further reports of this nature against products from lot 25085184.

• 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: 50035900
• Report Number: 9616066-2026-01878
• Device Sequence Number: 15939231
• Product Code: FPA
• UDI-Device Identifier: 10885403224782
• UDI-Public: (01)10885403224782
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown