MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. MICROBORE EXTENSION SET, IV CONNECTOR, T; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZXT9001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/06/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.B2.The date of death: unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
It is reported leakage.Description: we recently experienced a sentinel event involving the bd maxzero microbore extension set (ref: mzxt9001).The connection point leaked, which likely impacted the administration of critical medications.Medwatch: bd maxzero microbore extension set (ref: (b)(6)) connected to bd alaris pump infusion set (ref: (b)(6)) connection point between infusion set and extension set were connected but leaked.Patient was undergoing procedure required anticoagulation medications unclear if medications were fully infused due to leak.Lab values align with insufficient medication.Patient clotted and coded.Extensive efforts were utilized but care was ultimately withdrawn and patient passed.Pt code: 1762.Device code: 1250.Ref report: mw5182215.Additional information the patient was stable prior to this encounter involving this product.Date of the event 1-6-2026.Lot number associated with the product lot 25029194.Medication or fluid in use at the time of the event: sodium chloride 0.9 percent and heparin impact to the patient-please describe any patient harm, injury, complication, or negative outcome: life sustaining measures, death (care withdrawn).
Additional Manufacturer Narrative
One photo was received for quality evaluation.The photo shows a picture of the product unused and still in the packaging.The customer complaint of leakage could not be verified.A root cause investigation was not conducted because the photo provided does not show the failure reported.Additionally, a physical sample was not provided and therefore a detailed product investigation could not be conducted.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.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR, T
• 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: 24231091
• Report Number: 9616066-2026-00191
• Device Sequence Number: 21137460
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: (01)10885403240805
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown