MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD MAXZERO EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9226
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero extension set had leakage.The following information was provided by the initial reporter: we are having issues with our filter tubing leaking again.The lot number is 24089377.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Two samples were received for quality evaluation.There no visual damages or abnormalities.Both samples leaked at the filter vent when attempting to prime.The sample were then pressurized with air to determine if the filters were functioning properly.No air bubbles were release from the filter vents.The customer complaint of leakage was confirmed.The samples were forwarded to the supplier for root cause analysis.Due to information on the medication used with the sample not being provided, the sample could not be handled with certain safety.Based on the airflow test showing that no bubbles were released, this suggests that there is no damage / hole in the membrane, and that its hydrophobicity has been compromised by the drugs / solution in use.The root cause for the issue is unknown and the issue was possibly created by the drugs / solution used.A device history record review for model mz9226 lot number 24089377 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXZERO EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23336381
• Report Number: 9616066-2025-03206
• Device Sequence Number: 9451964
• Product Code: FPA
• UDI-Device Identifier: 10885403240621
• UDI-Public: (01)10885403240621(17)270818(10)24089377
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/16/2026

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: Other
• Device Catalogue Number: MZ9226
• Device Lot Number: 24089377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown