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

Catalog Number MPX5302-C

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd maxplus pressure rated extension set with needleless connector and y-site was damaged.The following information was received by the initial reporter with the verbatim: iv catheter came apart at the hub where the iv tubing branches.Iv catheter found in take in the patient's arm.Second part of the iv tubing was found on the floor.

Event Description

No additional information was provided.

Manufacturer Narrative

Dhr and device eval the customer reported the tubing came apart at the hub, and returned one used sample of material mpx5302-c and lot 23109359.The set was visually examined for defects and abnormalities.The separation at outlet of y-site was immediately noticed and the complaint was verified.Analysis under the microscope found insufficient solvent to be applied to the tubing/smart site connection.The manufacturing site conducted further analysis and found that the possible root cause of the separation at tubing/y-site connection is due to excessive solvent applied by the assembler.The solvent does not spread across the whole connection, and only covers part.A quality alert was issued 08mar2024 to communicate to the production personnel to reinforce the correct solvent application method and avoid the excessive solvent.Device history record review for model mpx5302-c lot number 23109359 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 03nov2023.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.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
• Type of Device: 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: 18426926
• MDR Text Key: 331924669
• Report Number: 9616066-2023-02461
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403237239
• UDI-Public: (01)20885403237239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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
• Device Operator: Other
• Device Catalogue Number: MPX5302-C
• Device Lot Number: 23109359
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1