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

Catalog Number	21-7022-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: additional related report number 3012307300-2024-13996, 3012307300-2024-14000 neither samples nor pictures were received for the analysis of this complaint.The device history record of reported lot number 4235003 was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the complaint will be reopened for further investigation.
Event or Problem Description
It was reported that the package was opened, installed, and the product was found to be leaking.There was no patient involvement.

• Brand Name: CADD ADMINISTRATION 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: 20837547
• Report Number: 3012307300-2024-14001
• Device Sequence Number: 14418784
• Product Code: FPA
• UDI-Device Identifier: 10610586019791
• UDI-Public: (01)10610586019791(17)270202(10)4235003
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: 21-7022-24
• Device Lot Number: 4235003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2022
• 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