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

Catalog Number	MZXT5306
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
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 pressure rated extension set was cracked the following information was received by the initial reporter with the following verbatim it was reported by customer that the t connector on extension set mzxt5306 is not securely fitting on the end of iv hub, leading to leaking of blood and medication.The luer lock connection is not seating properly to iv hub, leading to nurses spinning the spin collar and, in some cases, cracking it.
Additional Manufacturer Narrative
The customer reported the t connector is not securely fitting, and returned 3 unused samples of material mzxt5306, lot not 25085605.Upon initial visual examination, the sets had no defects or abnormalities.The issue of connection issues was unable to be replicated, and all connections on the t connector set were also able to hold watertight connections.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.The manufacturing site was unable to assign a root cause for the connection issue, due to the investigation being unable to replicate the failure.

• 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.; 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: 23751713
• Report Number: 9616066-2025-03708
• Device Sequence Number: 18521949
• Product Code: FPA
• UDI-Device Identifier: 10885403463815
• UDI-Public: (01)10885403463815(17)280818(10)25085605
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: MZXT5306
• Device Lot Number: 25085605
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown