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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7363-24
Medical Device Problem Codes Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/03/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No information has been provided to date.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.
 
Event or Problem Description
It was reported by the nurse that a crack was identified in the coil of the cadd administration set, which may have resulted in the patient receiving only approximately half of the prescribed vancomycin dose.The nursing staff had previously replaced the cadd administration set on (b)(6) 2026.On (b)(6) 2026, leakage from the line was observed.Upon identification of the leak, the administration set was replaced by the nursing staff.However, the patient returned to the stu due to continued leakage from the cadd bag.Upon further assessment, a crack was confirmed in the coil of the cadd administration set.It was determined that the compromised line may have resulted in partial delivery of the prescribed vancomycin dose.The event involved the patient; however, no harm was reported.
 
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Brand Name
CADD ADMINISTRATION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
avenida calidad no.4
parque ind internacional
tijuana 22425
MX  22425
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key25703766
Report Number3012307300-2026-06874
Device Sequence Number9804727
Product Code FPA
UDI-Device Identifier15019517161960
UDI-Public(01)15019517161960(17)300819(10)6145363
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K031361
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,User Facility
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 07/03/2026
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 Number21-7363-24
Device Lot Number6145363
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/15/2026
Initial Report FDA Received Date07/03/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured09/01/2025
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 Number1
Concomitant Medical Products
and Therapy/Usage Dates
VANCOMYCIN.
Patient SexUnknown
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