MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET ( EPIDURAL CATHETER ); SET, ADMINISTRATION, INTRAVASCULAR

Model Number	CADD EXTENSION SET
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Epidural infusion tubing was leaking at the filter site of the epidural tubing, this was discovered.This has happened multiple times with this & product/lot #.

• Brand Name: CADD EXTENSION SET ( EPIDURAL CATHETER )
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18102967
• Report Number: MW5147994
• Device Sequence Number: 6884613
• Product Code: FPA
• UDI-Device Identifier: 10610586034480
• UDI-Public: 10610586034480
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/06/2023

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: CADD EXTENSION SET
• Device Catalogue Number: 21-7108-24
• Device Lot Number: 4379834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White