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

Catalog Number	21-7309-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: five photos were attached to the complaint.No device was received.According to the photos, the customer's complaint of leaking was confirmed.No cause could be established due to the device not being returned.If the product is returned, this complaint will be reopened for further investigation.
Event or Problem Description
It was reported that the unit was observed to be leaking at the top right corner of the cadd at the joint between the tubing and the bladder.The product fault was observed during market process stage.There was unknown patient involvement and patient harm/adverse event reported.

• Brand Name: CADD RESERVOIR CASSETTE
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21277668
• Report Number: 3012307300-2025-01365
• Device Sequence Number: 9339871
• Product Code: FPA
• UDI-Device Identifier: 10610586032387
• UDI-Public: (01)10610586032387(17)290507(10)6005565
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: 6005565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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