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 MPX5305-C

Device Problems Complete Blockage (1094); Infusion or Flow Problem (2964)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that bdmaxplus pressure rated extension set with needleless connector and y-site was blocked the following information was received by the initial reporter with the following verbatim target; iv fluids to run at maximal flow rate without pressure bag application actual; bd maxplus refmpx5305-c pigtail extension set slows down iv flow rate at gravity (not on pump).Pressure bag used on iv fluids to improve flow rate.Gap; use of pressure bag to get iv fluids in.This pigtsil set is inappropriate substitution for larger bore tubing pigtail set.1.Are you able to provide the date of event in format dd-mmm-yyyy? 20/03/2024.2.Are you able to provide the batch/lot number? unknown.3.Was issue being described noted before, or during used? during use.4.Was there any patient involvement? yes.5.Any adverse events or serious injury reported to patient or healthcare professional? no.6.What was the patient outcome? unknown.7.Was there any delay of, or change in, the course of treatment due to this event? no.8.What procedure was being performed? iv bolus infusion.9.What medication was used in the procedure? n/a.10.Was there any medical intervention due to this event? no.11.Does a return shipping label need to be generated? if yes, kindly provide the sender¿s name and address.No.

Manufacturer Narrative

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

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of flow issues - fluid blockage (slow flow rate) could not be verified due to the product not being returned for failure investigation.A device history record review for material# mpx5305-c and lot# mpx5305-c was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12jan2024.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.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 Description

No additional information was provided.Material: mpx5305-c batch#: 24019185.It was reported by the customer that extension set slows down iv flow rate at gravity (not on pump).Pressure bag used on iv fluids to improve flow rate.Verbatim: please send all customer to communication to xxxx.Com, please do not include the customer, i'll forward to them.From customer contact #1: icare 317800.Target; iv fluids to run at maximal flow rate without pressure bag application actual; bd maxplus refmpx5305-c pigtail extension set slows down iv flow rate at gravity (not on pump).Pressure bag used on iv fluids to improve flow rate.Gap; use of pressure bag to get iv fluids in.This pigtsil set is inappropriate substitution for larger bore tubing pigtail set.1.Are you able to provide the date of event in format dd-mmm-yyyy? 20/03/2024.2.Are you able to provide the batch/lot number? unknown.3.Was issue being described noted before, or during used? during use.4.Was there any patient involvement? yes 5.Any adverse events or serious injury reported to patient or healthcare professional? no.6.What was the patient outcome? unknown.7.Was there any delay of, or change in, the course of treatment due to this event? no.8.What procedure was being performed? iv bolus infusion.9.What medication was used in the procedure? n/a.10.Was there any medical intervention due to this event? no.11.Does a return shipping label need to be generated? if yes, kindly provide the sender¿s name and address.No.Note: no further information available.From customer contact #2: the crna who filed the icare should be the one to answer these questions.(b)(6), are you able to answer the questions below? (b)(6), do you have a lot number from one of the sets returned to you yesterday? from customer contact #3: the product that was used in the event wasn¿t retrievable.The remainder of the sub product (mpx5305-c) removed from 5w.All marked lot # 24019185.

• 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: 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19117147
• MDR Text Key: 341251933
• Report Number: 9616066-2024-00574
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083472
• 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: 04/24/2024

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: MPX5305-C
• Device Lot Number: 24019185
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1