MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD YELLOW-STRIPED EXTENSION SET WITH MICRON FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7108-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the epidural infusion tubing had several leaks at the in-line filter site.The event occurred multiple times with the item.It is unknown if there was patient involvement, no adverse patient effects were reported.
Additional Manufacturer Narrative
H3: device not received by manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
This file is a retraction as the information was incorrectly filed under this registration number, please reference mrn 3012307300-2024-07892 for details pertinent to this event.

• Brand Name: CADD YELLOW-STRIPED EXTENSION SET WITH MICRON FILTER
• 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: 18449503
• Report Number: 9617604-2024-00011
• Device Sequence Number: 7780716
• Product Code: FPA
• UDI-Device Identifier: 10610586034480
• UDI-Public: 10610586034480
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 21-7108-24
• Device Lot Number: 4379834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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