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	06/06/2022
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) dial-a-flow is not allowing fluid to flow properly.The following information was provided by the initial reporter: i have received several cases of item number: mfs141, lot number: 22039046 where the dial-a-flow is not allowing fluid to flow properly.Even when the device is set to ¿open¿ it is very difficult to flush and it should easily flow through.
Event or Problem Description
It was reported that the bd maxguard flow controller extension set with needleless y-site(s) dial-a-flow is not allowing fluid to flow properly.The following information was provided by the initial reporter: i have received several cases of item number mfs141, lot number 22039046 where the dial-a-flow is not allowing fluid to flow properly.Even when the device is set to ¿open¿ it is very difficult to flush and it should easily flow through.
Additional Manufacturer Narrative
H6: investigation summary: four samples of unopened and unused extension set mfs141 were received for quality investigation.The customer complaint of flow issues - accuracy was verified by investigation.Evaluation of the samples submitted were conducted by first visually inspecting the samples.There were no kinks or component damage identified on any of the samples submitted.The flow controller was then tested for occlusion and flow.The mfs141 extension sets were tested with a syringe filled with water at the proximal end of the extension set, and the flow control regulator in the open position to determine if the flow control regulator allowed flow without restriction.After verifying flow in the open position, the flow control valve was then tested at 250 ml/hr, 100 ml/hr and the closed position to determine if flow was occluded in any of the indicated positions and if the flow was stopped in the closed position.Each of the flow control valve setting allowed flow or restricted flow as expected.The samples were then connected to a sample secondary infusion set and a saline infusion bag.The flow was controlled by the flow control valve set at 250 ml/hr.The infusion set was allowed to dispense saline for 10 minutes and then checked to see how much volume of saline was dispensed.Sample 1 showed that the flow controller allowed 53 ml to dispense in 10 minutes, equivalent to 318 ml/hr.Sample 2 showed that the flow controller allowed 48 ml to dispense in 10 minutes, equivalent to 288 ml/hr.Sample 3 showed that the flow control valve allowed for 42 ml to dispense in 10 minutes, equivalent to 252 ml/hr.Sample 4 allowed 35.5 ml to dispense in 10 minutes, equivalent to 213 ml/hr.In summary 3 of the 4 samples did not dispense the fluid at a rate that the flow control valve was set.A device history record review for model mfs141 lot number 22039046 was performed.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: 14961756
• Report Number: 9616066-2022-00852
• Device Sequence Number: 17866587
• Product Code: FPA
• UDI-Device Identifier: 10885403236471
• UDI-Public: 10885403236471
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 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: 03/03/2025
• 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: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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