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	MPX5300-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem 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 following verbatim it was reported by customer that there may be some extension sets that have a hole in them, letting blood spurt out and air flow in when placed on patients.
Additional Manufacturer Narrative
Two samples model mpx5300-c, lot 24109177 were returned for investigation.The sets were examined for defects and abnormalities.One set was separated at the tubing inlet port for the y-site.No other defects or abnormalities were observed.The other set was primed and tested for leakage.No leak was observed.Visual inspection under the microscope showed signs of lack of solvent for the one set that was separated.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the exact root cause of separation between tubing/ and nac-y (arm) could be related to an incorrect solvent application (lack of solvent) by assembler or due to issues with the solvent dispenser or related to an incorrect use of fixtures by the assembler due to not following the standard work instruction.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21580114
• Report Number: 9616066-2025-00498
• Device Sequence Number: 12978709
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: (01)10885403237218
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (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): 04/16/2025

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: MPX5300-C
• Device Lot Number: 24109177
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown