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	01/27/2023
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) was occluded during use.The following information was provided by the initial reporter: " situation: fluid bag is spiked; the flow controller is set to open and the line primes without issue.When the controller is set to the rate decide there is no flow.Occurred 7 times in last tow days.Rns moved to another device or used alaris pump.Background: the device is designed to be used in open mode to prime the tubing and then the rn can set the rate of flow per ordered rate.".
Event or Problem Description
It was reported that the bd maxguard¿ flow controller administration set with needleless y-site(s) was occluded during use.The following information was provided by the initial reporter: " situation: fluid bag is spiked; the flow controller is set to open and the line primes without issue.When the controller is set to the rate decide there is no flow.Occurred 7 times in last tow days.Rns moved to another device or used alaris pump.Background: the device is designed to be used in open mode to prime the tubing and then the rn can set the rate of flow per ordered rate.".
Additional Manufacturer Narrative
H6: investigation summary no sample ( mat # mfs102) received by the customer.Photos representation was provided for the complaint.It was reported by the customer that the product is having flow issues.However the failure could not be verified in the photos.A device history record review for model mfs102 and lot number 22029883 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this lot.Due to no sample being received a root cause could not be determined.

• 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 ; 8448235433
• MDR Report Key: 16464669
• Report Number: 9616066-2023-00288
• Device Sequence Number: 7482181
• Product Code: FPA
• UDI-Device Identifier: 10885403236334
• UDI-Public: 10885403236334
• 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): 04/05/2023

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: 02/28/2025
• Device Model Number: MFS102
• Device Catalogue Number: MFS102
• Device Lot Number: 22029883
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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