MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7092-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two sets of the device were leaking.The event occurred while use with patient at hospital.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2024-00555.The date of that submission was 01-jul-2024.B3: unknown; no information has been provided to date.E1: facility name "intermountain health lutheran infusion center".Phone number "(b)(6).H3/h6: one extension set was returned for analysis in used condition.The sample contained biological residues and therefore was too dirty to clean and perform functional analysis.Photos were reviewed.The photo shows an extension set in used conditions.The customer complaint of leaking was not confirmed.A device history review had no findings.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20002571
• Report Number: 3012307300-2024-07890
• Device Sequence Number: 20665663
• Product Code: FPA
• UDI-Device Identifier: 10610586024177
• UDI-Public: (01)10610586024177(17)281204(10)4448928
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K000942
• 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: Nurse
• 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: 21-7092-24
• Device Lot Number: 4448928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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