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

Catalog Number	MZX5306
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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 separated the following information was received by the initial reporter with the following verbatim material #mzx5306 lot #unknown it was reported by customer that he j-loop and then the collection device.He went to grab his tubes and realized that there was blood everywhere.The j-loop had completely broke away from the y-site, which then caused blood to run out of the j-loop.This patient was being held down by staff and security as he was placed in restraints and because of this malfunction in the tubing, xxx had some drops of blood land on his arm.We had to disconnect the broken j-loop from the catheter hub and reconnect a new one.
Additional Manufacturer Narrative
One sample model mzx5306 was returned for investigation.The set was examined for defects and abnormalities.The tubing was separated from the inlet port of the y-site.No other defects or abnormalities were observed.The customer complaint was verified, and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the potential root cause of separation could be related to an incorrect solvent application, gap by the assembler or issues with the solvent dispenser.A quality alert was generated on jul 22nd, 2025, to communicate and reinforce the correct solvent application.

• 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: 22214510
• Report Number: 9616066-2025-01591
• Device Sequence Number: 18179867
• Product Code: FPA
• UDI-Device Identifier: 10885403463792
• UDI-Public: (01)10885403463792
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• 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): 08/07/2025

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: MZX5306
• Device Lot Number: UNKNOWN
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• 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