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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxplus pressure rated extension set with needleless connector was damaged.The following information was received by the initial reporter with the following verbatim.Are you able to help me send a product complaint to bd regarding this iv extension that broke apart during a ct contrast injection? the nurse said it blew apart and contrast was spraying around the room.This occurred late wednesday night, 2/26.I checked with the ct staff and they told me contrast for that type of test flows at 4.5 ml per second with a pressure limit of 300 psi¿which this device is rated for 10 ml per sec and 325 psi.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: the customer reported a separation at the male luer on material mp5301-c, lot 24129188, and returned only a photo of the issue.The physical sample was reported to be returned under a label for a different complaint, (b)(4), which only received one sample.There is no physical sample for this complaint, however, the complaints have the same failure, lot, and material, and the plant response for (b)(4) will be shared along with this investigation.The manufacturing plant found the root cause for the separation issue to be related to incorrect solvent application.The plant did not take any actions to address the failure as the line for material mp5301-c was reactivated at a different bd plant, starting march 10th, 2025.The plant that produced this batch is no longer producing the material number.Although, no additional actions were taken for this complaint, a quality alert was generated on march 21st, 2025 to communicate and reinforce the correct solvent application method using a medica solvent dispenser to avoid separation between components.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.
Event or Problem Description
Photos received.

• 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: 21697881
• Report Number: 9616066-2025-00650
• Device Sequence Number: 8774233
• Product Code: FPA
• UDI-Device Identifier: 10885403236600
• UDI-Public: (01)10885403236600(11)241210(17)271210(10)24129188
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/15/2025

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: 24129188
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown