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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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) was clogged.The following information was provided by the initial reporter: the iv fluids would not flow through the dial a flow ¿ even when opened fully to 250ml/hr.Iv fluids infused well when dial a flow removed.
Additional Manufacturer Narrative
H.6.Investigation summary: no product or photo was returned by the customer.The customer complaint of flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation, however, similar issues has been reported for item mfs141.An investigation has been forwarded to the supplier of the flow control component.A device history record review for model mfs141 lot number 22059320 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.There is 1 quality notifications issued for the failure mode reported by the customer during the production build of this set.The quality notification is for the reported failure seen in this complaint.A supplier corrective action request has been submitted to the supplier of the component to correct the issue and explain how they will move forward to correct and monitor the issue from reoccurring.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.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd maxguard flow controller extension set with needleless y-site(s) was clogged.The following information was provided by the initial reporter: the iv fluids would not flow through the dial a flow ¿ even when opened fully to 250ml/hr.Iv fluids infused well when dial a flow removed.

• 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: 15279539
• Report Number: 9616066-2022-01211
• Device Sequence Number: 6889685
• Product Code: FPA
• UDI-Device Identifier: 10885403236471
• UDI-Public: 10885403236471
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/25/2022

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: 05/25/2025
• Device Model Number: MFS141
• Device Catalogue Number: MFS141
• Device Lot Number: 22059320
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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