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

Catalog Number	MP5301-C
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxplus pressure rated extension set had connection issues.The following information was received by the initial reporter with the following: it was reported by the customer that when removing the iv tubing from the extension set after the patient's antibiotics finished the tip of the iv tubing broke off in the extension set.The iv tubing become stuck in the extension set.Fairly common for staff to have difficulty removing iv tubing from the extension set.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of component damage - no leak and connection issues could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material mp5301-c because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET
• 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: 23333603
• Report Number: 9616066-2025-03146
• Device Sequence Number: 13211049
• Product Code: FPA
• UDI-Device Identifier: 10885403236600
• UDI-Public: (01)10885403236600
• Combination Product (Y/N): N
• 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): 10/07/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown