MAUDE Adverse Event Report: Sistemas Medicos Alaris S.A de C.V. BD MaxZero Pressure Rated Extension Set; Intravascular Administration Set

Catalog Number	MZ5303
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero pressure rated extension set had connection issues.The following information was provided by the initial reporter: a cathena iv was placed and a maxzero extension set was connected.The connection would not seal properly and blood leaked at the connection until the extension set was replaced.Extension set product information: material number: mz5303.Material description: bd maxzero.Batch number: 26045881.Additional information received from the customer: can you please provide an exact date of event in this format mm-dd-yyyy? date was 08-27-2026.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Minor blood loss (only a few ml), delay to blood sample collection and saline infusion, extension set had to be replaced with another one from the same lot.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD MaxZero Pressure Rated 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.; 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: 50840322
• Report Number: 9616066-2026-02381
• Device Sequence Number: 16018183
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: MZ5303
• Device Lot Number: 26045881
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown