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

Catalog Number	21-7309-24
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the cassette caused an occlusion alarm.There were reported three incidents with this batch.There were no clinical consequences reported.
Additional Manufacturer Narrative
D3.Manufacturing plant address, city, zip code, state, country: corrected.H6.Investigation codes: updated.Investigation summary: 22 samples were received.Samples consist of (b)(4) product from part number 21-7309-24, lot number 4422422.The samples were received in no-used conditions, decontaminated, with their original packaging.Pictures were attached to the complaint.Three photos were attached to the complaint, these samples were sent to be evaluated.Visual inspection: the sample was visually inspected at a distance of 12¿ to 16¿ under normal conditions illumination.Results: on the sample unit, no damage, scuffs, pinch marks, cracks, crazing, cuts, was observed.Functional testing: the samples were filled with 250 ml of colored water using a syringe to detect any occlusion.Results: no occlusion, leak or alarm in the pump were detected in the samples received.Conclusion: according to sample received, the failure mode ¿causes pump to alarm¿ was not confirmed in the devices received.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: CADD 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 MN ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20920596
• Report Number: 3012307300-2024-14831
• Device Sequence Number: 15532131
• Product Code: FPA
• UDI-Device Identifier: 10610586032387
• UDI-Public: (01)10610586032387(17)280825(10)4422422
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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 Catalogue Number: 21-7309-24
• Device Lot Number: 4422422
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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