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

Catalog Number	MZ5304
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located, and (b)(6) was used.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 the bd maxzero pressure rated extension set was occluded.The following information was provided by the initial reporter: we are able to flush these loops when they aren't connected to the patient, but once we connect and pull back to verify blood return, it will not allow us to flush.We have had to take the faulty ones off and exchange them with another j-loop and then it flushes fine.No injuries or complications occurred.
Additional Manufacturer Narrative
Investigation results: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.No product will be returned per customer.No investigation was performed.
Event or Problem Description
No additional information.

• 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 ; 8473935694
• MDR Report Key: 24448039
• Report Number: 9616066-2026-00511
• Device Sequence Number: 10372941
• Product Code: FPA
• UDI-Device Identifier: 10885403230578
• UDI-Public: (01)10885403230578(11)251107(17)281106(10)25115757
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 02/26/2026

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: MZ5304
• Device Lot Number: 25115757
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown