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	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxguard flow controller extension set with needleless y-site(s) experienced difficult to clamp or unclamp tubing.The following information was provided by the initial reporter: iv fluids not infusing though patient iv was patent, brisk blood return and flushing well.
Additional Manufacturer Narrative
The initial reporter also notified the fda on jul, 2022.Medwatch report #: (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of birth: patient¿s birthday was not provided, (b)(6) 1972 was used based on age of patient.
Event or Problem Description
It was reported that the bd maxguard flow controller extension set with needleless y-site(s) experienced difficult to clamp or unclamp tubing.The following information was provided by the initial reporter: iv fluids not infusing though patient iv was patent, brisk blood return and flushing well.
Additional Manufacturer Narrative
Investigation summary: one sample of item mfs141 was submitted by visual.The customer complaint of clamp issue / damage related to clamp was verified by testing.Evaluation of the sample submitted was conducted by first testing the extension set with a syringe and water.Water was attempted to be pushed through the extension set with a syringe and there was no occlusion noticed.The sample was then connected to a sample secondary infusion set with a sodium chloride infusion bag, and the flow control dial was set at 250 ml/hr and allowed to flow for 10 minutes.The amount of liquid dispensed was 38 ml.The flow rate obtained is approximately 228 ml/hr, below the selected 250ml/hr flow rate.A device history record review for model mfs141 lot number 22039100 was performed.The root cause for the issue seen in this complaint is an issue with the construction of the flow control valve.A supplier corrective action report was issued to the supplier of the flow control valves.Upon supplier investigation it was found that the internal gasket of the flow control valve becomes misaligned when turning the control valve, causing for occlusion and inaccurate flow as seen in the investigated samples.Corrective actions have been implemented at the supplier level, in order to, correct the issue.The flow control valves used in these assemblies were created prior to the corrective actions having been implemented.

• 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: 15158845
• Report Number: 9616066-2022-01042
• Device Sequence Number: 12249241
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 03/07/2025
• Device Model Number: MFS141
• Device Catalogue Number: MFS141
• Device Lot Number: 22039100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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 Age: 50 YR
• Patient Sex: Female