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

Catalog Number	MZXT9001
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd microbore extension set, iv connector, t had connection issues.The following information was provided by the initial reporter: material #mzxt9001.Batch # 25029194.Verbatim: t connector does not attach to iv hub.Attempted to demo product for customer but spin collar would not spin down on iv.Hub after inserting luer.
Additional Manufacturer Narrative
It was reported by customer that t connector does not attach to iv hub.One photo was received for quality evaluation.The photo received shows the product and the product packaging, however, it does not depict the reported issue.The customer complaint of connection issues could not be verified.A root cause was not determined because a physical sample was not provided and the photos provided does not show the issue reported.A device history record review for model mzxt9001 lot number 25029194 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
On sample of product mzxt9001 connected to and iv and one photo was received for quality evaluation.The photo received shows the product and the product packaging, however, it does not depict the reported issue.The physical sample was visually examined and no damages or abnormalities were identified.The sample was then connected to a bd needleless syringe, making sure that all connections were secure.A fluid push and a fluid draw was attempted in order to determine if any of the connections were loose or caused leakage.There were no leakages identified during testing.The customer complaint of connection issues could not be confirmed.A root cause was not determined because reported issue could not be replicated with the sample submitted.

• Brand Name: BD MAXZERO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24406842
• Report Number: 9616066-2026-00470
• Device Sequence Number: 9905673
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: (01)10885403240805(17)280208(10)25029194
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 02/24/2026

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: Health Professional
• Device Catalogue Number: MZXT9001
• Device Lot Number: 25029194
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown