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

Catalog Number	MZ5301
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 pressure rated extension set with needleless connector(s) was backflowing.The following information was received by the initial reporter with the following verbatim: customer reports that the extension set connected was connected to iv hub, blood was pulled out, then stopped and would not flush.When disconnected from iv hub, blood freely flowed from iv.Staff members report multiple incidents of the same thing happening.
Additional Manufacturer Narrative
The customer reported flow issues and returned one set of material mz5301, lot 24029138.Upon initial visual examination, the set had no defects or abnormalities.The set was primed and flushed with water, no occlusion or flow issues were observed.The complaint was not confirmed.Device history record review for model mz5301 lot number 24029138 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10feb2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Without a replication of the failure, the root cause could not be found.The root cause is potentially related to clinical practice, a member of our team was notified of the issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19507151
• Report Number: 9616066-2024-00864
• Device Sequence Number: 7376243
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: (01)10885403230547
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/02/2024

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: MZ5301
• Device Lot Number: 24029138
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown