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	Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 10 bd maxguard flow controller administration set with needleless y-site(s) experienced flow issue.The following information was provided by the initial reporter: i¿d like to report the below administration set for gravity infusion has been having problem with infusion.We could not prime the tubing; the results are either wasting the drugs and/or switching out the tubing set.This has resulted in delay of care and/or at risk for potential line infection issues.
Event or Problem Description
It was reported that 10 bd maxguard flow controller administration set with needleless y-site(s) experienced flow issue.The following information was provided by the initial reporter: i¿d like to report the below administration set for gravity infusion has been having problem with infusion.We could not prime the tubing; the results are either wasting the drugs and/or switching out the tubing set.This has resulted in delay of care and/or at risk for potential line infection issues.
Additional Manufacturer Narrative
H.6.Investigation summary: one video was returned by the customer.It was reported by the customer that the administration set for gravity infusion has been unable to prime.The video shows the set connected to a bag filled with fluid.The drip chamber contains fluid, however, the tubing is not priming despite the flow controller being fully open.The customer complaint can be verified.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 #(b)(4) 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.H3 other text : see h10.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16620193
• Report Number: 9616066-2023-00561
• Device Sequence Number: 17623238
• 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,Followup
• Report Date (Section B): 04/11/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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