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	MZ9275
Medical Device Problem Codes	Break (1069); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connectors luer-lock collar was broken and fell off the quad fuse.The following information was provided by the initial reporter: "upon disconnecting and attempting to reconnect quad fuse to femoral line, the connecting collar with threads fell off of quad fuse.Upon inspection, noticed collar was broken.".
Additional Manufacturer Narrative
H6: investigation summary: one sample was received and tested by our quality team.The cracked luer was obvious upon receipt and the customer's complaint was verified.The crack was clearly due to the application of a large crushing force at some point after assembly.The manufacturer was contacted for further investigation into the root cause.There is a possible root cause of damage during packaging process but without the packaging material or the lot this is impossible to determine- the root cause remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connectors luer-lock collar was broken and fell off the quad fuse.The following information was provided by the initial reporter: "upon disconnecting and attempting to reconnect quad fuse to femoral line, the connecting collar with threads fell off of quad fuse.Upon inspection, noticed collar was broken.".

• 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: 16438859
• Report Number: 9616066-2023-00265
• Device Sequence Number: 15264145
• Product Code: FPA
• UDI-Device Identifier: 10885403240768
• UDI-Public: 10885403240768
• 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
• 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): 03/27/2023

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 Catalogue Number: MZ9275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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