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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).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 2 bd maxguard flow controller extension set with needleless y-site(s) experienced leakage.The following information was provided by the initial reporter: if you take a syringe and attempt to flush it, it will not go through the dial-a-flow.The liquid leaks from within the device.
Additional Manufacturer Narrative
H.6.Investigation summary: 3 samples were received and tested by our quality team.The device was infused using saline solution at highest flow rate and leaks were realized in all three samples.This verified the customer's complaint.This issue has been escalated to both our manufacturing team and the supplier of the device components.The root cause for the issue seen in this complaint is an issue with the construction of the flow control valve.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.Upon supplier investigation it was found that the internal gasket of the flow control valve was misaligned causing for occlusion and leakage seen at the flow control valve location.A device history record review for model mfs141 lot number 22029169 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 03feb2022.H3 other text : see h.10.
Event or Problem Description
It was reported that 2 bd maxguard flow controller extension set with needleless y-site(s) experienced leakage.The following information was provided by the initial reporter: if you take a syringe and attempt to flush it, it will not go through the dial-a-flow.The liquid leaks from within the device.

• 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: 14427723
• Report Number: 9616066-2022-00614
• Device Sequence Number: 20209305
• Product Code: FPA
• UDI-Device Identifier: 10885403236471
• UDI-Public: 10885403236471
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/23/2022

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 Model Number: MFS141
• Device Catalogue Number: MFS141
• Device Lot Number: 22029169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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