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	MZ9273
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the bd maxzero¿ multi-fuse extension set with needleless connector, leaked from the tpn filter during use.The following information was provided by the initial reporter: "describe the event or problem; picc line infusing with tpn, smof lipids, and precedex.Tpn filter on pre-made trifurcate noted to be leaking for 2 days in a row".
Additional Manufacturer Narrative
E.4.Fda notified? the initial reporter also notified the fda via medwatch # 4900240000-2023-8038.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 04-may-2023 investigation summary 2 samples were received and tested by our quality team.The samples were primed and the leaks from filter were immediately noticed and the customer's complaint was verified.The sets were then sent to the supplier for further investigation.The supplier confirmed leak and analyzed the filter membranes to determine there were no visible issues with the devices.The leaks were determined to be most likely due to the medication infused at time of failure damaging the integrity of the hydrophobic air filter membranes.The root cause remains unknown.This type of complaint- leakage from filter is a known issue and is being investigated on multiple levels of our organization.The filter supplier, our manufacturing teams, r&d, and our quality engineers are all working diligently to determine the root causes and eliminate further occurrences from taking place.A device history record review for model mz9273 lot number 21116090 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector leaked from the tpn filter during use.The following information was provided by the initial reporter: "describe the event or problem: picc line infusing with tpn, smof lipids, and precedex.Tpn filter on pre-made trifurcate noted to be leaking for 2 days in a row.".

• 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: 16740455
• Report Number: 9616066-2023-00689
• Device Sequence Number: 17791442
• Product Code: FPA
• UDI-Device Identifier: 10885403240850
• UDI-Public: 10885403240850
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 07/26/2023

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: 11/18/2024
• Device Catalogue Number: MZ9273
• Device Lot Number: 21116090
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: Male