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 Codes	Complete Blockage (1094); Leak/Splash (1354); Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
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) experienced occlusion, leakage and foreign matter in fluid pathway.The following information was provided by the initial reporter: got an email from the doctor who said that the devices would not allow fluid to flow through despite being open.Water came out of the device.Unsure whether the device was being used for educational purposes.Not sure whether the water that came out was foreign matter or if it was part of the procedure.
Event or Problem Description
It was reported that the bd maxguard flow controller extension set with needleless y-site(s) experienced occlusion, leakage and foreign matter in fluid pathway.The following information was provided by the initial reporter: got an email from the doctor who said that the devices would not allow fluid to flow through despite being open.Water came out of the device.Unsure whether the device was being used for educational purposes.Not sure whether the water that came out was foreign matter or if it was part of the procedure.
Additional Manufacturer Narrative
H.6.Investigation summary: two samples model mfs141 were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were attached to a 10 ml bd syringe filled with water and attempted to flush while in the open position.The sets were successfully flushed with no leakage observed.The customer complaint that the devices would not allow fluid to flow through despite being open.Water came out of the device.Possible foreign matter leaking out could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model mfs141 lot number 22039100 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10mar2022.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 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: 15158709
• Report Number: 9616066-2022-01039
• Device Sequence Number: 12048553
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: Health Professional
• 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: 07/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/23/2022
• 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 Sex: Unknown