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	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd maxguard pressure rated extension set with y-site there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: ¿i believe we have a bad lot of these extensions.The fluid won¿t flush through the extensions with this lot number.¿ ¿ic pulled 3 pallets of ln 474450 with lot number 23039035.¿ ln 474450, set ext 8, lot 23039035 the huntsville team has pulled 3 pallets of the same lot # and put to the side.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 19-jun-2023 investigation summary: one used and ten unused samples model mx5301, lot 23039035.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were then connected to a 10 ml bd syringe filled with water and 8 unused samples were successfully flushed.Two unused and one used samples were unable to be flushed and excess solvent was observed near the female luer during visual inspection under a microscope.The customer complaint that the sets were unable to be flushed was replicated.A quality notification was sent to the manufacturer.From the manufacturers investigation, the potential root cause of occlusion between the tubing and female luer can be related to the application of solvent (excess) due to issues with the solvent dispenser.The mdgn dispenser will be replaced to avoid issues in the solvent application.A device history record review for model mx5301 lot number 23039035 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02mar2023.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 while using bd maxguard pressure rated extension set with y-site there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: ¿i believe we have a bad lot of these extensions.The fluid won't flush through the extensions with this lot number.¿ ¿ic pulled 3 pallets of ln 474450 with lot number 23039035.¿ ln 474450, set ext 8, lot 23039035 the huntsville team has pulled 3 pallets of the same lot # and put to the side.

• 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: 17313415
• Report Number: 9616066-2023-01423
• Device Sequence Number: 3995825
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 03/02/2026
• Device Catalogue Number: MX5301
• Device Lot Number: 23039035
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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