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

Catalog Number	MP5301-C
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus pressure rated extension set with needleless connector was occluded.The following information was provided by the initial reporter: customer reports not being able to use maxplus mp5301-c extension set for gravity infusion.Customer is placing the intracanal iv catheter and connecting it to the max plus extension set.Customer states that sometimes they are unable to get the fluid to flow in via gravity.Additional information received from the customer: 1.Kindly provide the batch/lot number of the product.The lot number of our current shipment is (10)24119189.When i asked our buyer if there were other lot numbers she advised me of only our current lot number.2.Kindly provide the date of event.There have been multiple dates, all have been in the last several months.3.Can you share any physical sample or photo if available for investigation? if yes, please provide the address of the facility for us to ship the return label? i do not have a sample of the nonfunctioning extension.They had been used and disposed of.No photos were taken.4.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Ivs were restarted before nurses realized the extension was not functioning.No healthcare professional was injured.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.Device evaluation: no product or photo was returned by the customer.The customer complaint of flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for material # mp5301-c and lot# 24119189 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08nov2024.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21860102
• Report Number: 9616066-2025-00941
• Device Sequence Number: 7888413
• Product Code: FPA
• UDI-Device Identifier: 10885403236600
• UDI-Public: (01)10885403236600
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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: MP5301-C
• Device Lot Number: 24119189
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown