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	MZ9283
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector quad-fuse broke midway through the flushing process.The following information was provided by the initial reporter: "quadfuse broke midway through flushing and hanging new lines.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary one sample of material number mz9283 was submitted for quality investigation.The customer complaint of component damage - leak was verified by inspection.Evaluation of the extension set shows that one of the extensions set tubes separated from bifurcated microbore.Further investigation under magnification shows a lack of solvent on the tubing.A device history record review for model mz9283 lot number 22119050 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure is the lack of solvent between the tubing and the adapter.The root cause for the failure is an incorrect application of the solvent in the assembly causing for a lack of solvent at the union between the adapter and the tubing.This process is called "gumming." the failure in the gumming process can be caused by the dispenser or by the distance of the dispenser and the assembly.A quality alert was generated to prevent future occurrences of this defect.
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector quad-fuse broke midway through the flushing process.The following information was provided by the initial reporter: "quadfuse broke midway through flushing and hanging new lines.".

• 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 ; 8015296192
• MDR Report Key: 16200458
• Report Number: 9616066-2023-00025
• Device Sequence Number: 17193845
• Product Code: FPA
• UDI-Device Identifier: 10885403230660
• UDI-Public: 10885403230660
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/31/2023

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: 11/08/2025
• Device Catalogue Number: MZ9283
• Device Lot Number: 22119050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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