MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET

Model Number	MFS102
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used sample model mfs102, lot 22029883 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to an iv bag filled with water and attempted to be flushed.The set was unable to be flushed.The male luer, y-site and flow controller was cut from the set.Flow was restored once the flow controller was cut from the line.No excess solvent was observed at the ports of the flow controller.The customer complaint that the set was unable to be primed was able to be confirmed.The root cause is caused by a misplaced gasket.Corrective actions have been taken to correct the issue and the component that was received was constructed before the corrective actions were put in place.Corrective actions include: 1) introduce controls during the assembly process to ensure 14 days of mechanical stabilization for the gasket.2) assembly: to produce parts with 14 days from assembly process.3) testing: all the parts produced without the above requirement will pass through 100% rotation and flow testing (material quarantined section).4) simulation of mechanical stabilization conditions.A device history record review for model mfs102 lot number 22029883 was performed.The search showed that a total of 5403 units in 1 lot number was built on 02mar2022.There were quality notifications issued for the failure mode reported by the customer during the production build of this set for lot 22029883 as notification id #200334871 on 07jul2022.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 that the bd maxguard¿ flow controller administration set with needleless y-site(s) failed to prime due to blockage.The following information was provided by the initial reporter: "we have another incident with tubing issue report on friday 3/10/23.Failed prime for this tubing.".

• Brand Name: BD MAXGUARD¿ FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(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 ; 8448235433
• MDR Report Key: 16640425
• Report Number: 9616066-2023-00593
• Device Sequence Number: 14794342
• Product Code: FPA
• UDI-Device Identifier: 10885403236334
• UDI-Public: 10885403236334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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
• Report Date (Section B): 03/14/2023

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: 02/28/2025
• Device Model Number: MFS102
• Device Catalogue Number: MFS102
• Device Lot Number: 22029883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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