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	05/26/2022
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 2 bd maxguard flow controller extension set with needleless y-site(s) were clogged.The following information was provided by the initial reporter: i have been told of 2 of the bd maxguard flow controller ext sets (dial-a-flows) not working at all.They are able to prime the controller extension but after priming no flow is allowed no matter the range that is selected.
Additional Manufacturer Narrative
H6: investigation summary.Two 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 10 ml bd syringe filled with saline and the flow controller in the open position.The set was unable to prime.The customer complaint that there is no flow was verified.A quality notification was sent to the manufacturer.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 mfs141 lot number 22039076 was performed.The search showed that a total of 11523 units in 1 lot number was built on 28jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.
Event or Problem Description
It was reported that 2 bd maxguard flow controller extension set with needleless y-site(s) were clogged.The following information was provided by the initial reporter: i have been told of 2 of the bd maxguard flow controller ext sets (dial-a-flows) not working at all.They are able to prime the controller extension but after priming no flow is allowed no matter the range that is selected.

• 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: 14834389
• Report Number: 9616066-2022-00768
• Device Sequence Number: 2366797
• 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): 09/16/2022

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: 03/04/2025
• Device Model Number: MFS141
• Device Catalogue Number: MFS141
• Device Lot Number: 22039076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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