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

Catalog Number	MZ9266
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxzero extension set was leaking.The following information was received by the initial reporter with the following: it was reported by customer that noticed a small amount of wetness on linen under 3-way t-connector.
Additional Manufacturer Narrative
The customer reported that the 3 way set was leaking, and returned one used sample of material mz9266, lot 25059083.In addition, an unknown concomitant mini extension set was attached as well.Upon initial visual examination, the set had no defects or abnormalities.The trifuse was infused with water from a 10 ml bd syringe, and the leakage was noticed from the maxzero and trifuse male luer connection.The connection was examined, and a crack in mz was found.The root cause for the crack in the maxzero was unable to be traced to a manufacturing process.The root cause us unknown.There is a potential root cause for excessive force applied to the component, this can be exacerbated by the use of alcohol wipes, which can cause a residue that makes the plastic harder to unscrew.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.

• Brand Name: BD MAXZERO EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23621691
• Report Number: 9616066-2025-03537
• Device Sequence Number: 18386948
• Product Code: FPA
• UDI-Device Identifier: 10885403240782
• UDI-Public: (01)10885403240782(11)250529(17)280528(10)25059083
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: MZ9266
• Device Lot Number: 25059083
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown