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

Catalog Number	MZ9226
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero extension set had leakage.The following information was provided by the initial reporter: epoprostenol was connected to crrt circuit using the microbore iv tubing with the inline filter that comes already in line with the tubing.This rn noticed pool of liquid under iv pump and then noticed the epo was dripping from where the syringe connects to the tubing.Rn tightened connection between syringe and tubing, but the medication still continued to drip from that area.Epo syringe and entire tubing set changed to microbore tubing with the removeable inline filter.No leaking noticed afterwards.
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
It was reported by the customer that hte rn noticed pool of liquid under iv pump and then noticed dripping from where the syringe connects to the tubing.One sample was received.A fluid push was attempted on the sample and there was no fluid flow.Further investigation under magnification indicates that there is a possible solvent blockage in the fluid line.The customer complaint of fluid blockage was confirmed.The customer complaint of leakage could not be confirmed because there was no flow through the sample.The investigation was forwarded to manufacturing for root cause analysis.After the investigation, it was determined that the occlusion between female luer and nac zero could be related to excess of solvent due to an incorrect solvent application by the assembler.Additionally, the failure mode was not detected during the production process since the 100% flow test was not correctly carried out as is established in the standard work instruction.A quality notification was created to address the failure.Non-conforming material was identified and segregated, and defective material was sorted and inspected.The reported product was discontinued at the manufacturing location of the identified batch.Finally the standard work instruction was updated at the remaining manufacturing location to assure the correct assembly between components.A device history record review for model mz9226 lot 24079130 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 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23372774
• Report Number: 9616066-2025-03244
• Device Sequence Number: 15940205
• Product Code: FPA
• UDI-Device Identifier: 10885403240621
• UDI-Public: (01)10885403240621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: MZ9226
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 03/04/2026
• 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