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

Catalog Number	MZ9265
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary a complaint of sets breaking apart easily was received from the customer.No sample was received for this complaint.A device history record review for model mz9265, lot number 22045768, was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 11apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 while using bd maxzero multi-fuse extension set with needleless connector(s) the set was broken.There was no report of patient impact.The following information was provided by the initial reporter: ext set is breaking apart when coming out of packaging.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 25-jan-2023.H6: investigation summary a complaint of sets breaking apart easily was received from the customer.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The set had separated at the maxzero, and the connection of the two maxzeros, and at the connection to the bottom half of the set.Some traces of solvent could be seen on the tubing.A device history record review for model mz9265 lot number 22045768 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect and an investigation was completed.The root cause was determined to be a lack of solvent added to the component, causing it to be easily separated.
Event or Problem Description
It was reported while using bd maxzero multi-fuse extension set with needleless connector(s) the set was broken.There was no report of patient impact.The following information was provided by the initial reporter: ext set is breaking apart when coming out of packaging.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• 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: 16346067
• Report Number: 9616066-2023-00180
• Device Sequence Number: 6318552
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: (01)10885403240775
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/08/2023

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: 04/11/2025
• Device Catalogue Number: MZ9265
• Device Lot Number: 22045768
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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