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

Catalog Number	MZ5309
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero pressure rated extension set was seaprated the following information was received by the initial reporter with the following verbatim it was reported by a customer that the tubing separated from the spin collar.
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
The customer reported there was a separation at the spin collar and returned one photo of the incident.The reported material is mz5309, and the lot is 25099002.There is no physical sample for investigation.The photo verified the complaint of the separation at the tubing/male luer connection.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 plant found the root cause for the separation to be related to incorrect solvent application.The original plant did not take any actions to address the failure as the line for material mz5309 was reactivated at a different bd plant, starting march 10th, 2025.The plant that produced this batch is no longer producing the material number.The plants are in communication regarding all quality issues during the changeover.The plant addressed the solvent application issue with a work instruction update detailing the use of a pin in the medica solvent dispenser, which assures correct solvent application between tubing and male luer.The production of mz5309 with the new process began on november 21st, 2025.The lot number reported was manufactured prior to this date.

• 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: 23751968
• Report Number: 9616066-2025-03719
• Device Sequence Number: 9428369
• Product Code: FPA
• UDI-Device Identifier: 10885403242083
• UDI-Public: (01)10885403242083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/27/2026

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: MZ5309
• Device Lot Number: UNKNOWN
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown