MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. EXT SET 8; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZX5305
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, y site started leaking and blood backed up.
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.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.
Additional Manufacturer Narrative
Investigation results: one set of model mzx5305 was returned for investigation.The unit was examined for defects and abnormalities, and none were initially observed.The y-site was flushed with water, at which time a leak was observed originating from the y-site.Subsequent visual inspection under a microscope revealed a crack extending along the y-site threads.The customer complaint was verified, and a quality notification was sent to the manufacturer.From the manufacturer's review of the complaint, according to customer words, condition reported was found during infusion, this led us to not be able to confirm that this is manufacturing related.The root cause is unknown.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• Brand Name: EXT SET 8
• 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: 24681081
• Report Number: 9616066-2026-00751
• Device Sequence Number: 13193370
• Product Code: FPA
• UDI-Device Identifier: 10885403463785
• UDI-Public: (01)10885403463785
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• 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): 05/14/2026

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: MZX5305
• Device Lot Number: UNKNOWN
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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