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

Model Number 21-7349-24

Device Problem Priming Problem (4040)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported the cadd set was not priming correctly.No patient injury was reported.

Manufacturer Narrative

Please disregard the initial report submitted with the mfr number: 3012307300-2022-07819.The report was submitted in error.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14310299
• MDR Text Key: 290946219
• Report Number: 3012307300-2022-07819
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517184235
• UDI-Public: 15019517184235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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
• Device Operator: Health Professional
• Device Model Number: 21-7349-24
• Device Catalogue Number: 21-7349-24
• Device Lot Number: 4230893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1