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

Catalog Number	21-7394-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
It was reported that an estimated 30¿50 ml of chemotherapy remained in the pump, though the exact amount was unknown.The pump started with 600 ml at a continuous rate of 25 ml/hr.Both reservoir and total volume given were recorded as 600 ml.The patient had been medically affected, requiring an additional 1¿2 hours of infusion time to complete the treatment.The event occurred while in use with a patient.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS 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: 22911585
• Report Number: 3012307300-2025-10103
• Device Sequence Number: 15758374
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: (01)10610586027536(17)291113(10)6071227
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: Lay User/Patient
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 6071227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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