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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus pressure rated extension set had separated.The following information was provided by the initial reporter: while an rn was starting an iv a piece of the saline lock broke off.Product that malfunctioned? reference#: mp5301-c, lot#: 25105490.What was the issue? while an rn was starting an iv a piece of the saline lock broke off.Were there any patient injuries? no.Were there any employee injuries? no.Was there any delay in patient treatment? none reported.
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
The customer reported the luer lock broke off and returned one photo of a bloody mp5301-c, lot 25105490.The photo verified the complaint of separation at the tubing/male luer connection point.There is no physical sample for investigation.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.The manufacturing plant was unable to verify the root cause for the separation without a physical sample.The photo does provide a potential root cause of incorrect solvent application by the assembler.A quality alert was issued by the plant on 18feb2026 to communicate and reinforce the correct solvent assembly procedure to personnel.

• 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24178883
• Report Number: 9616066-2026-00109
• Device Sequence Number: 18646105
• Product Code: FPA
• UDI-Device Identifier: 10885403236600
• UDI-Public: (01)10885403236600
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 03/01/2026

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: 25105490
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/12/2026
• 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