MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter also sent report to fda?: yes, medwatch mw5107253.No product sample was received; therefore, visual and functional testing could not be performed and root cause could not be determined.No lot number was provided; therefore, a device history record (dhr) review could not be completed.

Event Description

It was reported that the cassettes were defective.The cassettes were replaced and the issue resolved.No patient injury was reported.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-06030.The report was submitted in error.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15285665
• MDR Text Key: 305288282
• Report Number: 3012307300-2022-06030
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female