MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BDMAXZERO MULTI FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	DV-MZXT9001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.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 bd maxzero multi fuse extension set with needleless connector was leaking the following information was received by the initial reporter with the following verbatim: email verbatim: ¿during harsh infusion test, two samples were identified leaking on july 9.And these two samples were re-test late on july 23, only one found leak.The failed sample will be used for root cause analysis.The leak locates on upper seal of the septum.
Additional Manufacturer Narrative
The customer is internal bd and a sample was sent to tj site as well as photos provided to dchu.The photos were examined, and the sample tested, but the issue could not be replicated.The component of the nac-t did not replicate the failure.
Event or Problem Description
Material #mzxt9001 - batch #20x227 during design verification of product maxzero extension set design defects was found.Email verbatim: ¿during harsh infusion test, two samples were identified leaking on july 9.And these two samples were re-test late on july 23, only one found leak.The failed sample will be used for root cause analysis.The leak locates on upper seal of the septum¿.

• Brand Name: BDMAXZERO 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19927343
• Report Number: 9616066-2024-01097
• Device Sequence Number: 8375616
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: (01)10885403240805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: DV-MZXT9001
• Device Lot Number: 20X227
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown