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

Model Number	MFS141
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd maxguard flow controller extension set with needleless y-site(s) experienced flow issues.The following information was provided by the initial reporter: the nurses are having issues with the flow regulators (mfs141) not working properly.They report a hard resistance in the beginning and then the flow rate almost stops at some spots or not be as it should, i.E.At 100 there was no flow but at full open they had flow.
Event or Problem Description
It was reported that the bd maxguard flow controller extension set with needleless y-site(s) experienced flow issues.The following information was provided by the initial reporter: the nurses are having issues with the flow regulators (mfs141) not working properly.They report a hard resistance in the beginning and then the flow rate almost stops at some spots or not be as it should, i.E.At 100 there was no flow but at full open they had flow.
Additional Manufacturer Narrative
H6: investigation summary: 21 unused/unopened samples (model #mfs141) were returned by the customer.It was reported that the flow regulators are not working properly.The sets were connected to a bd 10ml syringe, and fluid was attempted to be flushed through the sets when the dial was set to "open" and at every rate.10 of the unused sets were able to flow in the "open" state and at every rate without occlusions or leaks.The other 11 unused sets were able to flow without occlusions or leaks when the sets were fully opened.However, at every flow rate, flow was blocked and fluid leaked through the flow controller when attempting to be flushed.The customer complaint can be verified.A quality notification has been sent to the supplier, and the samples have been sent for further investigation.The supplier was able to confirm the failure.All 11 samples were found to have the flow blocked.The root cause of the blocked flow is due to the gasket (valve) being misplaced.The gasket did not have proper mechanical stabilization before the assembly.This causes the gasket to stick to the flow regulator body and get misplaced at first rotation.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.This long term verification will lead to confirmation of the root cause issue that has been identified, and to confirm or modify the days of mechanical stabilization for the molded gasket before the assembly.A device history record review for model mfs141 lot number 22029867 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13mar2022.The search also showed that a total of (b)(4) units in 1 lot number was built on 02mar2022.There was a quality notification issued for the failure mode reported by the customer during the production build of this set as notification id on 11jul2022.H3 other text : see h10.

• Brand Name: BD MAXGUARD FLOW CONTROLLER EXTENSION 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 ; 8015296192
• MDR Report Key: 14429285
• Report Number: 9616066-2022-00618
• Device Sequence Number: 17800946
• Product Code: FPA
• UDI-Device Identifier: 10885403236471
• UDI-Public: 10885403236471
• 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): 07/25/2022

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: 03/03/2025
• Device Model Number: MFS141
• Device Catalogue Number: MFS141
• Device Lot Number: 22039046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 08/17/2022
• 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