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

Model Number	7300
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during production using the 100 ml yellow cadd cassettes (pn 21-7300-24), a 100% visual inspection identified two cassettes with particles.The majority of the cassettes used were from lot #6092860; however, since units from other lots were also used, it is not possible to specify a single lot.Lot #6092860 has already been filed under a previous complaint ((b)(4)), and lot #6116309 has also been filed under a previous complaint ((b)(4)).These cassettes are used by integradose for the delivery of the controlled substances fentanyl citrate and ropivacaine hcl; therefore, we are unable to return the product.The particle appears similar to those previously observed at integradose.Sample photo and video were provided.
Additional Manufacturer Narrative
D4 lot#: possible lot numbers 6092860, 6116309, 6116313.H3: no product was returned but one video and one photo were attached to the complaint.In the video and photo, a particle was detected in the fluid path.According to video and photo received, the failure mode ¿a0226 - particulate inside the fluid path¿ was confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• 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: 23498219
• Report Number: 3012307300-2025-12224
• Device Sequence Number: 9037994
• Product Code: FPA
• UDI-Device Identifier: 10610586027192
• UDI-Public: (01)10610586027192(10)
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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 Model Number: 7300
• Device Catalogue Number: 21-7300-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2014
• 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