MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. MINIBORE PRESSURE, REMOVABLE IV CNNCTR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ5302
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported leak.Verbatim: rn caring for patient noted that the patient's linen was saturated with tpn.Upon inspection of picc line, noticed that the jloop had fluid leaking at the cap.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported leaking, and it was unknown to be the trifuse or the jloop, the jloop being the mz5302 material lot unknown.The customer returned two used mz5302 samples, and one used trifuse maxzero.Upon initial visual examination, the set had no defects or abnormalities.The sets were tested, and it was clear the leakage was caused by the jloop, or mz5302, rather than the trifuse.The maxzeros on the mz5302 both leaked, and verified the complaint.The maxzeros were examined under a microscope, and microcracks were found in the maxzero luer.A device history record review was not performed as the lot number is "unknown" for this complaint.The manufacturing plant was unable to trace the reported issue to the manufacturing process.The root cause is unknown.

• Brand Name: MINIBORE PRESSURE, REMOVABLE IV CNNCTR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 24149785
• Report Number: 9616066-2026-00083
• Device Sequence Number: 21165937
• Product Code: FPA
• UDI-Device Identifier: 10885403230554
• UDI-Public: (01)10885403230554
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: Health Professional
• Device Catalogue Number: MZ5302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 01/26/2026
• 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