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

Catalog Number	MX5301
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial report facility name is more then 50 characters: (b)(6).H3.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 pressure rated extension set with y-site would not flush.The following information was provided by the initial reporter: when flushing in an attempt to start an iv the nurse noticed the item did not flush.
Additional Manufacturer Narrative
H.6.Investigation summary: one sample model mx5301, lot 23059039 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a 10 ml bd syringe filled with water.The set was unable to be flushed.Further visual inspection under the microscope showed excess solvent near the female luer.The customer complaint that the set was unable to be flushed was replicated.A quality notification was sent to the manufacturer.From the manufacturers investigation, the potential root cause can be related to the application of solvent.The failure mode was addressed and approved on (b)(6) 2023 where the mdgn dispenser will be replaced by medical dispenser to avoid issues in the solvent application.A device history record review for model mx5301 lot number 23059039 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mx5301 lot number 23059039 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd maxguard pressure rated extension set with y-site would not flush.The following information was provided by the initial reporter: when flushing in an attempt to start an iv the nurse noticed the item did not flush.

• Brand Name: BD MAXGUARD PRESSURE RATED EXTENSION SET WITH 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17494944
• Report Number: 9616066-2023-01707
• Device Sequence Number: 12730632
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: (01)10885403237553
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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 Expiration Date: 05/02/2026
• Device Catalogue Number: MX5301
• Device Lot Number: 23059039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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