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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.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 damaged the following information was received by the initial reporter with the following verbatim: reported issue: (b)(6): pt exhibiting wat behaviors including, sbs greater than 1, difficult to console, and gagging.(b)(6): pt had been sleeping, resting, woke up in distress after first set of ett retape.(b)(6): dilaudid drip continued alarm of "occlusion", myself and rn (b)(6) assessed tubing, and found quad fuse had cracked, being the cause of the occlusion.Alaris alarm had not been alarming all night until event and had been alarming a ton suddenly.(b)(6): quad fuse may be disfunctional.Other rn's around unit stating quad fuses had been cracking/dysfunctional as well.
Additional Manufacturer Narrative
It was reported by customer that unit stating quad fuses had been cracking and dysfunctional as well.One sample of an unidentified product was submitted.The sample did not match the reported product mz9275.The customer complaint of a crack in the mz9275 item number could not be verified due to the sample not matching the product reported.Due to a sample that did not match the product reported, an investigation could not be performed and a root cause could not be determined.A device history record review could not be performed because the lot number is unknown.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
No additional information was provided.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19412499
• Report Number: 9616066-2024-00808
• Device Sequence Number: 8507826
• Product Code: FPA
• UDI-Device Identifier: 10885403240768
• UDI-Public: (01)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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: MZ9275
• Device Lot Number: UNKNOWN
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown