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 Codes	Leak/Splash (1354); 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
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector snapped apart and leaked out ivf and chemo.The following information was provided by the initial reporter: "bd maxzero lot #: 22045768 bifuse have been breaking super easily.We have had numerous problems on different patients with them breaking.While opening package and pulling bifuse out of the packaging it got caught and easily snapped apart.Pulled on the other side of bifuse to see if it would come apart easily and it did.In any of the occurrences did any leakage occur? if so, what leaked? ivf & chemo.".
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector snapped apart and leaked out ivf and chemo.The following information was provided by the initial reporter: "bd maxzero lot # 22045768 bifuse have been breaking super easily.We have had numerous problems on different patients with them breaking.While opening package and pulling bifuse out of the packaging it got caught and easily snapped apart.Pulled on the other side of bifuse to see if it would come apart easily and it did.In any of the occurrences did any leakage occur? if so, what leaked? ivf & chemo.".
Additional Manufacturer Narrative
Investigation summary: the sample is not available for return after a mix-up occurred.The samples were returned under a shipping label for a different complaint, along with the samples for other complaint.The samples never got to the investigation lab and thus an investigation could not be performed.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 complaint of bifuse breaking easily could not be confirmed.The root cause of this failure could not be identified without a failure investigation.

• 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: 16348743
• Report Number: 9616066-2023-00184
• Device Sequence Number: 12341753
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: 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): 04/27/2023

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?: No
• 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: 04/27/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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