MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9265
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector leaked at the connection site during the priming and infusion.The following information was provided by the initial reporter: "microbore bi-fuse extension set leaked at the connection site during priming and infusion.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 22109362.D4: medical device expiration date: 31oct2025.H4: device manufacture date: 31oct2022.H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that the extension set leaked at the connection site during infusion could not be verified due to the product not being returned for failure investigation.A device history record review for model mz9265 and lot number 22109362 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector leaked at the connection site during the priming and infusion.The following information was provided by the initial reporter: "microbore bi-fuse extension set leaked at the connection site during priming and infusion.".
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 19-sep-2023.H.6.Investigation summary: 1 sample received of mat# mz9265.It was reported by the customer that the extension set leaked at the connection site during infusion.Prior to functional testing the samples were visually examined for defects and abnormalities.No other defects or abnormalities were observed.The set were connected to a 10 ml bd syringe filled with water and attempted to be flushed by giving a pressure test.No leakage observed in pressure test.Also, the fluid pass through the sample easily.There were no leaks or connection issues witnessed during testing.No further issues were identified.The root cause for the issue reported could not be determined because the failure could not be replicated.A device history record review for model mz9265 and lot number 22109362 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31oct2022 also the searches showed that a total of(b)(4) units in 1 lot number was built on 27oct2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.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
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector leaked at the connection site during the priming and infusion.The following information was provided by the initial reporter: "microbore bi-fuse extension set leaked at the connection site during priming and infusion.".

• Brand Name: BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16710173
• Report Number: 9616066-2023-00658
• Device Sequence Number: 20315970
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: 10885403240775
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2023

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 Expiration Date: 10/31/2022
• Device Catalogue Number: MZ9265
• Device Lot Number: 22109362
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 09/19/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/31/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown