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

Catalog Number	MFS141
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxguard flow controller extension set with needleless y-site had flow issue.The following information was received by the initial reporter with the following verbatim: rn was able to prime tubing with iv fluid, once dial was turned to appropriate flow rate, all flow ceased.Unable to flush from above the dial, but able to flush below.Rn attempted to turn dial back to 'open' setting and was still not able to obtain any flow.
Additional Manufacturer Narrative
The customer reported occlusion in a mfs141 set, and returned one used set, unknown lot.The set was visually examined and no issues were observed.Then, the set was infused with water from a bd syringe, at all flow rates on the dial, and all of them showed occlusion.The complaint of flow issues was verified.The supplier of the flow rate dial was contacted about the failure.But they were unable to provide a root cause.The supplier will continue to monitor the issue for and trends.A device history record review could not be performed because the lot number is unknown.
Event or Problem Description
No additional information.

• Brand Name: BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20233449
• Report Number: 9616066-2024-01322
• Device Sequence Number: 8912502
• Product Code: FPA
• UDI-Device Identifier: 10885403236471
• UDI-Public: (01)10885403236471
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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 Catalogue Number: MFS141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown