MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. EXT SET SMALLBORE .2MF PED; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10011865
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported occlusion.Description: new piv [peripheral iv] placed on infant's leg with poor venous access.2 rns attempted piv placement then consulted rnts [registered nurse trauma specialist], who was unsuccessful, then placed vad (vascular access) consult.Vad rn able to place piv with ultrasound after 6 total attempts.Infant then connected to maintenance fluids.Pump began alarming occluded.This rn flushed piv with no resistance, added arm board, and retraced lines with no sign of occlusion.This rn then called vad for help troubleshooting.Alaris channel switched out and pump continues to alarm occluded.Vad rn suggests placing new iv on patient, assuming iv may be occluded at bend of the knee.As last effort, this rn disconnects iv tubing to allow fluids to run wide open and notices fluids do not run through until disconnected from 0.2 filter.Defective 0.2 micron filter is then replaced and reconnected to patient with no further issues.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.Device evaluation no product or photo was returned by the customer.The customer complaint of flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for material # 10011865 and lot# 25019140 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09jan2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: EXT SET SMALLBORE .2MF PED
• 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.; 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: 24189687
• Report Number: 9616066-2026-00122
• Device Sequence Number: 9513866
• Product Code: FPA
• UDI-Device Identifier: 10885403233647
• UDI-Public: (01)10885403233647(17)280109(10)25019140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 01/12/2026

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: 10011865
• Device Lot Number: 25019140
• 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: 01/07/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Male