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

Catalog Number	21-7022-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a defect/error with a cadd administration set that lead to chemotherapy leaking prior to administration.The pharmacy staff reviewed two additional cadd administration sets and the same thing happened to those - that the tubing separates from the plastic base quite easily, which could result in leakage.The event occurred prior to administration.It is unknown if the product is available for investigation.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Three photos were reviewed for the device evaluation.The reported problem was unable to be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Additional Manufacturer Narrative
D9: 13-feb-2025.H3: one used administration set from lot number 6026702 was received for evaluation.As received, the tubing was observed to be separated from the housing on the outgoing side.Inspection of the area showed evidence of solvent on both the tube and the cassette.Functional testing was not able to duplicate the reported issue.No leakage was observed during any functional tests.The device tested normally.

• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21337207
• Report Number: 3012307300-2025-01628
• Device Sequence Number: 8459250
• Product Code: FPA
• UDI-Device Identifier: 10610586019791
• UDI-Public: (01)10610586019791(17)290713(10)6026702
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: Health Professional
• Device Catalogue Number: 21-7022-24
• Device Lot Number: 6026702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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