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

Catalog Number	21-7346-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cadd administration set during infusion of reconstituted ertapenem 1 g with nacl using a cadd administration set, the set required approximately 10 ml to fully prime instead of the expected 6 ml.Infusion was initiated and flow was initially visualized in the line.With approximately 17 ml remaining in the 110 ml bag, the client reported that infusion in the line had stopped despite the pump remaining active.Upon handling the medication bag, leakage was observed at the junction where the blue plastic cap met the vial.The infusion was stopped, and health care professional was contacted and advised that no further action was required.A mini bag flush infusion was then initiated, and flow was again visualized; however, after approximately 10 ml infused, the client reported the infusion had stopped while the pump remained active.The infusion was stopped, the line was flushed with a syringe, and patency was confirmed.Leakage may lead to exposure and can result in interruption of therapy.There was patient involvement, and no harm reported.
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.Distributor details: lourdes bije-the stevens company limited.

• 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; industrial internacional; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25360022
• Report Number: 3012307300-2026-05643
• Device Sequence Number: 10613172
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: (01)15019517161953(17)300111(10)6085301
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: 21-7346-24
• Device Lot Number: 6085301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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 Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERTAPENEM 1 G WITH NACL, UNK MFR
• Patient Sex: Unknown