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

Catalog Number	MZ9267
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located, and il 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 microbore extension set had connection issues.The following information was provided by the initial reporter: bd maxzero microbore extension set iv connector tubing # mz9267 is very difficult to disconnect from the needlefree connector it's being attached to.The male connector is stuck in the microclave of the piv extension set.The nurses have been using hemostats to disconnect the iv tubing from the patient iv.In some cases this issue caused the clave to no longer be anti-reflux and the pt had blood coming out of the line.This has been reported on multiple units.Customer uses 50,000+ each per year and this has only just become an issue the past couple of weeks.
Additional Manufacturer Narrative
One photo was received for quality evaluation.Inspection of the photo shows that a luer connector was broken inside of an unidentified blue automatically closing connector.The photo confirms that the luer connector was difficult to separate from the corresponding connector, however, the photo does not depict the flow issues - back flow reported by the customer.Due to no sample being received, and because the product had already been manipulated before the failure was realized, a root cause analysis could not be conducted.A device history record review for model mz9267 lot number 25055188 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Additional Manufacturer Narrative
It was reported by customer that difficult to disconnect from the needle free connector it's being attached to.One photo was received for quality evaluation.Inspection of the photo shows that a luer connector was broken inside of an unidentified blue automatically closing connector.The photo confirms that the luer connector was difficult to separate from the corresponding connector, however, the photo does not depict the flow issues - back flow reported by the customer.Due to no sample being received, and because the product had already been manipulated before the failure was realized, a root cause analysis could not be conducted.A device history record review for model mz9267lot number 25055188 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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No further information was provided.

• Brand Name: BD MAXZERO MICROBORE 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.; 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: 22956943
• Report Number: 9616066-2025-02651
• Device Sequence Number: 8404653
• Product Code: FPA
• UDI-Device Identifier: 10885403240720
• UDI-Public: (01)10885403240720(17)280507(10)25055188
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2025

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: MZ9267
• Device Lot Number: 25055188
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 12/26/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/22/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown