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

Model Number	7346
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the patient reached out yesterday regarding ongoing issues with air appearing in the bags after priming and preparation without any visible air however, after the bags sat for some time, visible air was observed.This issue occurred with multiple lot numbers, and yesterday alone there were seven instances reported.For this the remaining 5 did not have a reported lot number available.The patient believed the issue was related to the filter in the set.The tubing was primed via gravity.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
D3 - postal code, h3, h6: updated.The suspect product sample was returned for evaluation.The sample was filled with degassed water in the product using a syringe and leak test was performed using hydrostatic pressure pump.It was found that there were no leakages observed.The administration sets were primed and left hanging under controlled ¿worst-case¿ conditions for three days to check for air entry.No significant air accumulation was observed in the sample during this period.Any small air bubbles seen were attributed to residual air or natural gas release from the liquid and not due to the product issues.One sample was retested with the end cap connected instead of clamping and left for 10 days.Only small air pockets were observed, attributed to residual air in the bag and natural gas release from the liquid.The allegation made by the complainant could not be confirmed and the probable root cause of the event could not be identified.

• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24780272
• Report Number: 3012307300-2026-03279
• Device Sequence Number: 12278410
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: (01)15019517161953
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• 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,Followup
• Report Date (Section B): 06/25/2026

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 Model Number: 7346
• Device Catalogue Number: 21-7346-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PHASEAL OPTIMA CSTD.
• Patient Sex: Unknown