MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2024-00011.The date of that submission was 04-jan-2024.No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The root cause was unable to be established.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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.

• Brand Name: CADD YELLOW-STRIPED EXTENSION SET WITH MICRON FILTER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20004748
• Report Number: 3012307300-2024-07892
• Device Sequence Number: 20056321
• Product Code: FPA
• UDI-Device Identifier: 10610586034480
• UDI-Public: (01)10610586034480(17)280303(10)4379834
• 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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