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

Model Number	MFS102
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
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 administration set with needleless y-site(s) experienced occlusion.The following information was provided by the initial reporter: it lets you run the iv solution through it to prime it but once hooked to a patient iv the tubing will not flow.Tried multiple tubings from same lot and having same issues.
Event or Problem Description
It was reported that the bd maxguard flow controller administration set with needleless y-site(s) experienced occlusion.The following information was provided by the initial reporter: it lets you run the iv solution through it to prime it but once hooked to a patient iv the tubing will not flow.Tried multiple tubings from same lot and having same issues.
Additional Manufacturer Narrative
Investigation summary: one used sample and 20 unused samples were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were attached to a bag filled with normal saline and allowed to flow.All unused samples flowed.The one used sample did not flow.The customer complaint that the tubing will not flow could be replicated.The root cause is caused by a misplaced gasket.Corrective actions have been taken to correct the issue and the component that was received was constructed before the corrective actions were put in place.A device history record review for model mfs102 lot number 22029884 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXGUARD FLOW CONTROLLER ADMINISTRATION 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: 14722417
• Report Number: 9616066-2022-00723
• Device Sequence Number: 12051623
• Product Code: FPA
• UDI-Device Identifier: 10885403236334
• UDI-Public: 10885403236334
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 02/28/2025
• Device Model Number: MFS102
• Device Catalogue Number: MFS102
• Device Lot Number: 22029884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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