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

Catalog Number	MX4450
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda notified?: the initial reporter also notified the fda via medwatch #(b)(4).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 5 bd maxguard¿ extension sets with needleless y-site and stopcock were blocked during the priming process.The following information was provided by the initial reporter: "5 reports where the maxguard extension sets do not prime as a patient is being prepared for surgery.Multiple reports of attempting to prime for patient care and iv fluid set up for surgery and the sets do not prime with fluid, there is some kind of occlusion within the set.".
Additional Manufacturer Narrative
Investigation summary no product or photo was returned by the customer.It was reported by the customer that the extension set will not prime with fluid, there is some kind of occlusion with the set.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model mx4450 lot number 22099402 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that 5 bd maxguard¿ extension sets with needleless y-site and stopcock were blocked during the priming process.The following information was provided by the initial reporter: "5 reports where the maxguard extension sets do not prime as a patient is being prepared for surgery.Multiple reports of attempting to prime for patient care and iv fluid set up for surgery and the sets do not prime with fluid, there is some kind of occlusion within the set.".

• Brand Name: BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK
• 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: 17048674
• Report Number: 9616066-2023-01064
• Device Sequence Number: 6984623
• Product Code: FPA
• UDI-Device Identifier: 10885403274671
• UDI-Public: 10885403274671
• 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): 08/14/2023

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: Other
• Device Catalogue Number: MX4450
• Device Lot Number: 22099402
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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