MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7394-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they received a call from a patient¿s home health nurse reporting leakage from the patient¿s iv unasyn infusion.The patient was instructed to discontinue use of the affected medication, switch to a new one, and return the original medication to our facility for evaluation.As a result, the remaining medication had to be discarded.Upon receiving the returned bag, our team conducted an initial inspection.At that time, no visible leaks were identified from the bag and cadd admin set itself.We also examined the enclosure and connection point between the cadd administration set and the bag and found no apparent issues at those junctions.However, the patient reported a sensation of dampness around the filter area.To further investigate, they hung the bag of fluid and left the tubing in a bucket overnight with the line clamped and plugged.When we returned in the morning, there was fluid in the bucket leading us to believe the line definitely leaked from somewhere.This has been reported a few times by different patients.Sample photos provided by customer have been attached to this record.The patient reported the leakage during his infusion.He mentioned feeling wet around the filter (square area).The patient had an additional iv bags with cadd admin to use.The patient had to waste the bag of medication.The medication amipicillin-sulbactam 12gm continuous infusion at a rate of 25 ml/hr.The manufacturer was auromedics.The concentration of the medication was 20 mg/ml, infused via central line.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
H3: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25245960
• Report Number: 3012307300-2026-05282
• Device Sequence Number: 21263676
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: (01)10610586027536(17)310226(10)6177155
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 21-7394-24
• Device Lot Number: 6177155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown